Thursday Miscellany

Medicare

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Medical / Rx research, Medicare, NCQA, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Per HHS press releases, HHS issued the following proposed rules released today (links are to fact sheets);
    • a proposed rule to update Medicare payment policies and rates for the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) for fiscal year (FY) 2025,
  • and
    • a proposed rule (CMS-1810-P) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2025,
  • and
    • “a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for fiscal year (FY) 2025.” 
  • Here is the fact sheet for the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) final rules regarding short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage under the Affordable Care Act released today. 
  • Per the American Medical Association News,
    • The Office of Management and Budget March 28 released its final updated standards for Federal agencies on maintaining, collecting and presenting data on race and ethnicity. Last updated in 1997, the revised Statistical Policy Directive Number 15 is the product of an OMB Interagency Technical Working Group on Race and Ethnicity Standards. While SPD 15 does not mandate race and ethnicity data collection by federal agencies, it requires federal agencies to adhere to standardized data definitions, collection and presentation practices wherever they do collect or use such data. Among other changes, the revised SPD 15 requires that race and ethnicity be collected using a single question with multiple responses, superseding OMB’s previous requirement to collect Hispanic ethnicity as a separate question. In addition, SPD 15 adds a category for Middle Eastern or North African (MENA) as a minimum reporting category and requires federal agencies to collect more detailed information on race and ethnicity beyond the seven minimum reporting categories. However, agencies may request and receive exemptions from OMB in instances where the potential benefit of more detailed data do not justify the additional burden to the agency or the public, or where the collection of more detailed data would threaten privacy or confidentiality. 
    • The updated SPD 15 is effective immediately. However, federal agencies have until March 28, 2029, to bring existing data collection and reporting activities into compliance with the updated SPD 15 and must submit action plans to OMB on how they will comply with the requirements by Sep. 28, 2025.
  • OPM made a passing reference to this guidance today on the second day 0f the OPM carrier conference.
  • The Labor Department’s Office of Federal Contractor Compliance Programs issued “Updated Annual Hiring Benchmark and New Benchmark Resources” for the veteran’s affirmative action in employment law that applies to FEHB carriers.

From the public health and medical research front,

  • Mercer discusses weight management in the era of GLP-1 drugs.
  • The NIH Director, in her blog, points out that an “Immune Checkpoint Discovery Has Implications for Treating Cancer and Autoimmune Diseases.”
  • The Washington Post reports,
    • “Diabetes, air pollution and alcohol consumption could be the biggest risk factors for dementia, study has found.
    • “Researchers compared modifiable risk factors for dementia — which is characterized by the impairment of memory, thinking and reasoning — and studied how these factors appear to affect certain brain regions that are already particularly vulnerable to Alzheimer’s disease and schizophrenia.
    • “The research, based on brain scans of nearly 40,000 adults, between ages 44 and 82, in Britain was published Wednesday in Nature Communications.”
  • Health Day informs us,
    • “Some folks struggling with obesity appear to be hampered by their own genes when it comes to working off those extra pounds, a new study finds.
    • “People with a higher genetic risk of obesity have to exercise more to avoid becoming unhealthily heavy, researchers discovered.
    • “Genetic background contributes to the amount of physical activity needed to mitigate obesity. The higher the genetic risk, the more steps needed per day,” said senior researcher Douglas Ruderfer, director of the Center for Digital Genomic Medicine at Vanderbilt University Medical Center in Nashville, Tenn.”
  • MedPage Today lets us know,
    • “For adults who are immunocompromised, the updated 2023-2024 COVID-19 vaccine reduced risk of hospitalization compared with not getting the shot, according to CDC data.
    • “Vaccine effectiveness against hospitalization was 38% in the first 7 to 59 days after receipt of the updated monovalent XBB.1.5 COVID vaccine, and 34% in the 60 to 119 days after receipt, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.
    • “However, despite the positive effect, only 18% of people in this high-risk population had received the updated COVID vaccine, “representing a missed opportunity to prevent severe COVID-19,” the authors wrote.”
  • Medscape notes,
    • “Starting an exercise regimen with others can be a powerful fitness motivator, and new research spotlights the strategy’s particular importance for older adults.
    • “In a randomized clinical trial in JAMA Network Open, older adults who talked with peers about their exercise program were able to increase and sustain physical activity levels much better than those who focused on self-motivation and setting fitness goals.
    • “Such self-focused — or “intrapersonal” — strategies tend to be more common in health and fitness than interactive, or “interpersonal,” ones, the study authors noted. Yet, research on their effectiveness is limited. Historically, intrapersonal strategies have been studied as part of a bundle of behavioral change strategies — a common limitation in research — making it difficult to discern their individual value.
    • “We’re not saying that intrapersonal strategies should not be used,” said study author Siobhan McMahon, PhD, associate professor and codirector of the Center on Aging Science and Care at the University of Minnesota, in Minneapolis, Minnesota, “but this study shows that interpersonal strategies are really important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The first major U.S. health insurers have agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions.
    • “CVS Health,  Elevance Health, and Kaiser Permanente said they would cover 
    • “Novo Nordisk’s Wegovy for the use of reducing the risk of heart attacks and strokes in people who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan.
    • “Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan.
    • “Some of the plans, including Kaiser Permanente’s, are making the coverage change effective immediately, while others, including those served by Elevance, will do so in the coming weeks.”
  • Axios informs us,
    • “The federal process for resolving billing disputes for out-of-network care has to date yielded payouts well above what Medicare and most in-network private insurers would pay providers, according to a new Brookings Institution analysis provided first to Axios. 
    • “Why it matters: That could lead to downstream effects like higher premiums — quite the opposite of what Congress intended when it passed a law banning surprise medical bills in 2020.
    • “What they found: Brookings analyzed Centers for Medicare and Medicaid Services data on arbitration decisions to settle disputed claims during the first half of 2023. 
    • “Researchers specifically focused on emergency care, imaging and neonatal and pediatric critical care.
    • “Across the three categories, median payouts were at least 3.7 times what Medicare would pay, Brookings found. 
    • “For emergency care and imaging, the median decision was at least 50% higher than the most generous payments commercial plans historically made, on average, for in-network care. 
    • “Similar estimates weren’t available for neonatal and pediatric critical care.
    • “The analysis concludes that there is a “realistic possibility” that the law will wind up raising in-network prices and, in turn, premiums.
    • “That’s the opposite of what the Congressional Budget Office predicted would happen.”
  • Interesting study but its conclusion is undercut by the fact that many providers accept the qualifying payment amount the the plans initially pay under the No Surprises Act.
  • Per Healthcare Dive,
    • Walgreens reported an almost $6 billion net loss in the second quarter, according to financial results released Thursday. Nearly all of that sum was attributable to the declining value of a single play: VillageMD, the primary care chain into which Walgreens has poured billions of dollars, but which has generated disappointing returns to date.
    • Walgreens was forced to write down VillageMD’s value after its financial team flagged a mismatch in the subsidiary’s value as recorded in its balance sheet and its value in the market, CFO Manmohan Mahajan told investors on a Thursday morning call. That discrepancy led Walgrens to record a $5.8 billion goodwill impairment charge.
  • and
    • “UCI Health has completed its $975 million purchase of four Southern California hospitals from Tenet Healthcare, the academic health system said Tuesday. Tenet announced the sale in February as part of an ongoing effort to fund debt repayment.”
  • and
    • “Ascension has signed a definitive agreement to divest three hospitals and an ambulatory surgical center in northern Michigan to MyMichigan Health, the health systems said Tuesday. 
    • “The deal includes Ascension St. Mary’s in Saginaw, Ascension St. Joseph in Tawas City, Ascension St. Mary’s in Standish and ambulatory surgery center and emergency department Ascension St. Mary’s Towne Center in Saginaw. Related care sites and physician practices are also included. 
    • “Ascension has recently sold other hospitals as the nonprofit expands its ambulatory and telehealth footprint.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • From a Senate press release,
    • Today, Senator Rick Scott and Senator Tom Carper announced the bipartisan FEHB Protection Act to stop fraud within the Federal Employee Health Benefits (FEHB) program, the largest employer-sponsored health insurance program in the country which covers eight million federal employees, retirees and family members. The FEHB Protection Act will codify Government Accountability Office (GAO) and Office of Inspector General (OIG) recommendations to require the Office of Personnel Management (OPM) to verify eligibility before adding family members, additionally, the bill requires an audit and removal of those ineligible for the program to ensure taxpayer dollars are used wisely and program benefits are protected for truly eligible individuals. This legislation follows a study conducted by the GAO at Senator Scott’s request, which revealed that OPM’s mismanagement of the FEHB program allowed ineligible individuals to obtain employer-sponsored health coverage at the hefty price tag of approximately $1 billion in taxpayer dollars every year.
    • The FEHBlog doubts the accuracy of GAO’s projection because half of the FEHB enrollment is self only and FEHB family sizes are notoriously small. In any case, this approach will not solve the problem because OPM reports enrollment actions and premiums separately even though using the HIPAA 820 electronic enrollment roster transaction would allow carriers to confirm receipt of premium for each enrollee systematically.
  • From the American Hospital Association News,
    • The Centers for Medicare & Medicaid Services March 27 finalized a rule proposed in 2022 to standardize Medicaid and CHIP enrollment and renewal processes and make it easier for eligible children and adults to stay covered. According to CMS, the final rule eliminates CHIP waiting periods, annual and lifetime coverage limits and the practice of locking children out of coverage if a family is unable to pay premiums; improves the transfer of children from Medicaid to CHIP when a family’s income rises; gives individuals at least 15 days to provide additional information when applying for the first time and 30 days to return documentation when renewing coverage; prohibits conducting renewals more often than every 12 months; and prohibits in-person interviews for older adults and those with disabilities. The rule takes effect 60 days after publication in the April 2 Federal Register.
  • and
    • The Centers for Medicare & Medicaid Services March 27 released the fiscal year 2025 proposed rule for inpatient rehabilitation facilities, which would update IRF payments by an estimated 2.8% overall (or $280 million) in FY 2025. This includes a 3.2% market basket update, which is reduced by a 0.4% productivity adjustment. IRF payments would be further decreased by an estimated $25 million due to the proposed update for outlier payments.
  • and
    • The Department of Health and Human Services’ Administration for Strategic Preparedness and Response and Centers for Medicare & Medicaid Services this week released a guide to health plan resources for health care providers impacted by the Change Healthcare cyberattack, including health plan contact information, noting in an accompanying letter that many providers continue to face significant disruptions as a result of the cyberattack or difficulty getting information from health plans about prospective payments and other flexibilities. The letter also encourages providers to review HHS’ voluntary cybersecurity performance goals.
  • It is worth adding that the United Healthcare Group updated its Change Healthcare Cyberattack response page today.

From the public health front,

  • The Washington Post reports,
    • “On Monday, government leaders in Puerto Rico declared a dengue epidemic after a spike in cases of the mosquito-borne disease hit the island.
    • “From the start of the year through March 10, there were 549 cases, including 341 hospitalizations and 29 severe cases, according to the most recent data provide by the Puerto Rico Department of Health. Cases are concentrated in cities including San Juan, Bayamon, Guaynabo and Carolina.
    • “Between 2010 and 2020, more than 30,000 dengue cases were reported from four U.S. territories, with Puerto Rico reporting the most. In 2012, Puerto Rico reported 199 deaths, which was the last time the commonwealth declared a dengue epidemic.”
  • The Wall Street Journal ponders,
    • “How closely should you be tracking your blood-sugar levels? * * *
    • “Soon, people without diabetes will be able to buy a monitor without needing to cajole a doctor into prescribing them one. The Food and Drug Administration recently approved the over-the-counter sale of a continuous glucose monitor, also known as a CGM. The devices allow people to continuously monitor their blood sugar levels.
    • “People who obsess over their health data or have an unhealthy relationship with food should avoid CGMs, most doctors say. Users might misinterpret normal glucose fluctuations as unhealthy, causing anxiety and prompting them to restrict certain foods. It isn’t clear that healthy patients would benefit from using a CGM over the long term.
    • “However, people at higher risk of developing diabetes, and those who are interested in working with their doctors to make lifestyle changes, might find it helpful. The technology could spot early signs of insulin resistance, possibly helping otherwise healthy people avoid Type 2 diabetes, some doctors say. 
    • “If we identify these patients sooner, we can suggest lifestyle modifications as well as maybe the initiation of weight-loss medications,” says Dr. Brenda Dorcely, an endocrinologist at NYU Langone Health.” 

Tidbits from the OPM FEHB carrier conference

  • The FEHBlog attended OPM’s virtual FEHB carrier conference today. Here are some tidbits.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Beleaguered health system Steward Health Care has agreed to sell its physician network, Stewardship Health, to healthcare behemoth UnitedHealth Group for an undisclosed sum, according to documents filed with Massachusetts regulators on Tuesday.
    • “Under the deal, UnitedHealth’s care delivery subsidiary Optum Care would acquire Steward’s nine-state footprint of primary care providers and clinicians. It will also acquire all of Stewardship’s stock. 
    • “The Health Policy Commission, an independent Massachusetts agency tasked with monitoring state healthcare spending, will have 30 days to assess the potential impact of a Optum-Steward deal on healthcare costs, quality and access, HPC director David Seltz said in a statement. Already, some legislators and health M&A experts are urging a close review of the transaction, citing antitrust concerns.”
  • Per MedTech Dive,
    • “Johnson & Johnson is in talks to acquire Shockwave Medical, The Wall Street Journal reported Tuesday, citing people familiar with the matter.
    • “A deal could come in the next few weeks. However, the report noted that talks could fall through, or another company could pick up Shockwave. J&J and Shockwave both told MedTech Dive they do not comment on market rumors or speculation.
    • “Shockwave makes medical devices that break up calcium deposits in coronary arteries using sound pressure waves, a technique called intravascular lithotripsy (IVL).”
  • Beckers Payer Issues offers an interview with Aetna’s chief medical officer about managed care lessons from Medicaid to Medicare.

Monday Roundup

David Ermer–Cybersecurity, Federal employment benefits, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News reminds us,
    • “The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans.
    • “Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox. Those rules will come out no later than April 1.
  • Becker’s Hospital CFO Report adds,
    • “Onerous” authorization requirements and high denial rates have health systems considering whether to drop Medicare Advantage plans, according to a report from the Healthcare Financial Management Association and Eliciting Insights. 
    • “HFMA Health System CFO Pain Points Study 2024” is based on a survey of 135 health system CFOs conducted in January. 
    • According to the report, 16% of health systems are planning to stop accepting one or more Medicare Advantage plans in the next two years. Another 45% said they are considering the same but have not made a final decision.
    • Health systems have been increasingly pushing back on Medicare Advantage. Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s last year that “it’s becoming a game of delay, deny and not pay.” Scripps terminated Medicare Advantage contracts effective Jan. 1 for its integrated medical groups. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners. Mr. Van Gorder said the health system was facing an annual loss of $75 million on MA contracts.  
    • “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed,” he said.
    • Despite tensions with some health systems, the Medicare Advantage program had a 95% quality satisfaction rating among enrolled members in 2023.
  • The FEHBlog notes that MA plans are subject to the Affordable Care Act’s medical loss ratio. The medical loss ration encourages health plans to make payments to providers.
  • FedSmith lets us know,
    • The Federal Salary Council (FSC) recently proposed adding about 15,000 federal employees to existing locality pay areas for 2025 from the “Rest of the U.S.” Being added to a locality pay area usually results in higher pay for impacted employees.
    • FSC is recommending the Pay Agent add Wyandot County, OH, to the Columbus, OH, locality pay area and Yuma County, AZ, to the Phoenix, AZ, locality pay area. These recommendations do not create new locality pay areas. In this case, they are adding employees to existing pay areas using various techniques to reduce employees in the “Rest of the U.S.” and add more to higher-paying locality pay areas.
    • A proposal from the Federal Salary Council does not mean a decision to make these additions is finalized. The recommendations have to be approved by the President’s Pay Agent. That approval usually follows, although not necessarily in the recommended time frame. Once the Pay Agent decides to move ahead, the Office of Personnel Management has to issue a proposed change in the Federal Register and a final decision in the Federal Register a few months later.
  • Reg Jones, writing in Fedweek, discusses “Survivor Annuity Benefits for Children of Deceased Federal Employees and Retirees.”
  • KFF discusses Medicare spending on GLP-1 drugs, like Ozempic, to treat diabetes.
    • “Gross spending on Ozempic alone increased from $2.6 billion in 2021 to $4.6 billion in 2022, pushing it to 6th place among the top-selling drugs in Medicare Part D that year, up from 10th place the year before.  
    • “The fact that covering GLP-1s under Medicare Part D for authorized uses is already making a mark on total Part D program spending could be a sign of even higher spending to come as Part D plans are now able to cover Wegovy for its heart health benefits, and if new uses for GLP-1s are approved.”
  • CNBC adds,
    • “Americans can’t seem to get enough of weight loss drugs despite their limited insurance coverage and roughly $1,000 monthly price tags before discounts. 
    • “But some patients are willing to pay more out of pocket for those treatments than others — and it’s strongly correlated to their annual income.
    • “That’s according to a recent survey from Evercore ISI that focused on GLP-1s, which include Novo Nordisk’s weight loss injection Wegovy and diabetes counterpart Ozempic.

From the public health and medical research front,

  • The American Medical Association advises its members about measles, now at 64 cases, and tells patient what doctors wish they knew about vasectomies.
  • Medscape shares five things to know about Adult Respiratory Syncytial Virus (RSV) Infection.
  • The Washington Post features a Consumer Reports article on maintaining kidney health. “Hydration and exercise are just two of the keys to reducing the risk of kidney disease.”
  • The Society for Human Resource Management offers nine mental health questions for employee engagement surveys.
  • CNN reports,
    • “Drugmaker Eli Lilly warned this week that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a “brief delay in manufacturing.”
    • “The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday [March 20]. The company said that prefilled pen versions of those medicines are still available in the US and that it continues to manufacture the 10-milliliter vials “and will ship them as soon as we can.”

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Hospitals are adding billions of dollars in facility fees to medical bills for routine care in outpatient centers they own. Once an annoyance, the fees are now pervasive, and in some places they are becoming nearly impossible to avoid, data compiled for The Wall Street Journal show. The fees are spreading as hospitals press on with acquisitions, snapping up medical groups and tacking on the additional charges. 
    • “The fees raise prices by hundreds of dollars for widely used and standard medical care, including colonoscopies, mammograms and heart screening. 
    •  “Hospitals say facility fees help offset the extra costs that they incur to meet federal regulations. “It’s not as simple as same services, across-the-board,” said Jason Kleinman, director of federal relations for the American Hospital Association.” * * *
    • “Lawmakers and Congress have proposed limiting fees covered by Medicare, which advisers to the federal insurer have unanimously recommended. Under a bill passed by the House in December, Medicare would no longer pay hospital facility fees for chemotherapy and other drugs infused by doctors in clinics off a hospital campus, saving about $3.7 billion over 10 years. 
    • “The American Hospital Association opposes limiting the fees, saying restrictions would cut revenue to hospitals already squeezed financially by high labor costs and inflation.”   
  • Beckers Hospital CFO Report adds,
    • “Kaufman Hall’s latest “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals, outlined three key areas that separate high-performing hospitals’ and low-performing hospitals when it comes to their operating performances: 
      • “Outpatient revenue. In general, hospitals with higher and accelerating outpatient revenue are more profitable.
      • “Contract labor. Hospitals that quickly reduced their percentage of contract labor demonstrate improved operating profitability. In addition, hospitals that aggressively marched down contract labor costs were correlated to rising wage rates for full-time staff. Rising wage rates appeared to attract and retain full-time staff, which has allowed those hospitals to decrease contract labor more quickly, all of which has led to increased profitability, according to the report. 
      • “Average length of stay. A lower average length of stay corresponded with improved profitability. Hospitals that hyper-focused on patient throughput — which has led to appropriate and prompt patient discharge — have also proven this to be a solid financial strategy, according to the report.”
    • “Hospitals on the other end of the scale continue to struggle, with the poorest financially performing hospitals reporting negative margins from -4% to -19%, according to Kaufman Hall. Continuation of this level of performance is unsustainable and makes it impossible to reinvestment in community care.” 
  • Per BioPharma Dive,
    • “Novo Nordisk will pay as much as $1 billion to acquire RNA drug developer Cardior and its experimental treatment for heart failure, the companies announced Monday. 
    • “Cardior’s treatment, dubbed CDR132L, is currently being tested in a mid-stage study involving 280 people with heart failure who previously experienced a heart attack. Results are expected by September, according to a U.S. clinical trial database.
    • “In addition to that study, Novo said it plans to start another Phase 2 trial in heart failure patients whose heart muscle has become thick and stiff, also known as cardiac hypertrophy. Novo, which will pay an undisclosed upfront payment to Cardior per deal terms, expects the acquisition to close in the second quarter.”
  • and
    • “Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company Landos Biopharma.
    • “Per the deal, Abbvie will buy Landos for $20.42 per share, or about $138 million. Abbvie has also agreed to pay a so-called contingent value right worth $11.14 per share, or another $75 million, if certain milestones are met. The upfront price represents a premium of about 155% to the closing price Friday of Landos stock.
    • “Landos is currently running a mid-stage trial of its lead drug, dubbed NX-13, in ulcerative colitis. Abbvie is also interested in NX-13’s potential in Crohn’s disease.”
  • Per Healthcare Dive,
    • “Change Healthcare said its largest claims clearinghouses would come back online over the weekend, more than a month after a cyberattack at the technology firm disrupted the healthcare sector. 
    • “More than $14 billion in charges have been prepared for processing, according to an update from parent company UnitedHealth Group on Friday. Change’s electronic payments platform has also been restored, and the company is working on payer implementations.”

Thursday Miscellany

David Ermer–AHRQ, CDC, CMS, Congress, Cybersecurity, Electronic health records, FDA, HSA, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Lawmakers released a more than $1.2 trillion, six-bill appropriations package early Thursday morning, less than 48 hours ahead of a Friday night deadline for this second and final wrapup measure for the fiscal year that began Oct. 1. 
    • “Both parties were touting “wins” in the package well before unveiling the massive 1,012-page bill, which had already won President Joe Biden’s blessing and pledge to sign it “immediately.” That, plus the lure of a two-week recess, should help get the package over the finish line, though it seems likely to slip past the 11:59 p.m. Friday cutoff for the current stopgap spending law.
    • “But lawmakers weren’t really sweating the prospect of a weekend funding lapse, given its limited impact on government operations — especially with Friday’s expected House passage likely to be a strong signal of congressional intent to keep the lights on.”
  • The bill includes appropriations for OPM (pages 247 – 250) and its Inspector General (page 250) plus the three now standard appropriations measures:
    • A prohibition against imposing full Cost Accounting Standards coverage on FEHB carriers. Division B, Section 611, page 268.
    • The Hyde amendment limiting FEHB coverage of abortions to cases “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest.” Division B, Section 613 and 614, pages 268 – 269.
    • A contraceptive prescription drug coverage mandate with conscience protections for FEHB plans and healthcare providers. Division B, Section 726, page 298.
  • The American Hospital Association News discusses HHS appropriations, which also are included in this bill.
    • “The House may vote on the measure Friday, with Senate action expected over the weekend. A short government shutdown may occur over the weekend, depending how long it takes both chambers to pass the measure and for President Biden to sign it into law.” 
  • Govexec points out “the nine biggest agency and program reforms in the final FY24 spending package.”
  • The Wall Street Journal scoops,
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday. * * *
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday.”
  • STAT News adds,
    • “Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction is “very, very, exciting,” Nora Volkow, the director of the National Institute on Drug Abuse, said Thursday.
    • “But even as she expressed enthusiasm for the new drugs’ potential, Volkow criticized pharmaceutical companies for neglecting a moral imperative to develop new addiction treatments — but acknowledged that the health system more broadly doesn’t incentivize drug companies to treat the U.S. drug crisis with urgency.”
  • The U.S. Preventive Services Task Force finalized its research plan for re-evaluating its September 2019 recommendations on the topic of medications to reduce the risk of breast cancer.
  • Beckers Health IT interviews Alexandra Mugge, chief health informatics officer at CMS, about the agency’s efforts “to expedite prior authorizations, through digitization and better data exchange, saving the healthcare industry $15 billion over a decade — in the hopes of one day having the decisions made instantaneously, right in the EHR.”

From the Food and Drug Administration front,

  • Per a press release,
    • “Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
    • “DMD denies the opportunity for a healthy life to the children it affects. The FDA is committed to advancing the development of new therapies for DMD,” said Emily Freilich, M.D., director of the Division of Neurology 1, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation.”
  • MedTech Dive informs us,
    • Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed updating its instructions for use.
    • The Food and Drug Administration identified the recall as a Class I event, the most serious type of recall, in a Thursday notice. The agency has received 129 reports of serious injuries, including 49 deaths, related to the problem. 
    • Abiomed’s Impella heart pumps, which are used to support the heart during procedures or during cardiogenic shock, were the subject of four Class I recalls last year, including the latest recall. The company also received an FDA warning letter for quality problems with Impella and software used in the device that had not been authorized by the agency.

From the public health and medical research front,

  • The CDC shares with us,
    • Data from the National Vital Statistics System
      • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.
      • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.
      • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.
      • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.
      • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).
  • STAT News adds,
    • “The U.S. recorded 107,941 drug overdose deaths in 2022, according to a new federal report — a total that marks an all-time record but also shows signs that the country’s overdose rate may finally be leveling off after years of steady increase.
    • “The 2022 total marks only a slight increase from the drug death toll of 106,699 the year before, according to the Centers for Disease Control and Prevention. The flattening of drug death rates could provide a rare glimmer of hope amid the bleak U.S. drug crisis, which has seen overdose rates rise inexorably for the past two decades and especially during the Covid-19 pandemic.
    • “A large majority of those deaths were driven by the potent synthetic opioid fentanyl. Since emerging in the drug supply in the mid-2010s, fentanyl has increasingly come to dominate the U.S. illicit drug market. Even as fentanyl deaths have skyrocketed, the share of deaths involving other opioids — like heroin, methadone, and prescription painkillers — has decreased.”
  • The Washington Post reports,
    • “After once losing hope because of end-stage kidney disease, a 62-year-old man is now the first living person to receive a genetically edited kidney from a pig, according to doctors at Massachusetts General Hospital who performed the landmark surgery Saturday.
    • “Richard Slayman, whom doctors praised for his courage, is doing well after the four-hour surgery and is expected to be discharged from the Boston hospital soon, officials said.
    • “The advance, which builds on decades of work, gives hope to the hundreds of thousands of Americans who depend on dialysis machines to do the work of their failing kidneys. Each day, 17 Americans die awaiting a kidney transplant, a problem further complicated by unequal access given to Black and other patients. Doctors expressed hope that using pigs to vastly increase the supply of kidneys might correct the inequity.”
  • The Wall Street Journal lets us know,
    • “A new class of anticoagulant drugs on the horizon is taking fresh aim at one of cardiology’s toughest challenges: how to prevent blood clots that cause heart attacks and strokes, without leaving patients at risk of bleeding.
    • “At least a half-dozen experimental blood thinners are in development that inhibit a protein called factor XI, one of several blood factors that regulate how the body forms clots. * * *
    • “Any factor XI agent that reaches the market would likely represent an important advance over drugs called factor Xa inhibitors, a blockbuster class of medicines dominated by Eliquis and Xarelto. Since they were approved just over a decade ago, these drugs have supplanted warfarin as the standard-of-care anticoagulant to prevent stroke in patients with the heart-rhythm disorder atrial fibrillation as well as other indications.”
  • HealthDay informs us,
    • “About 1 in every 10 U.S. children ages 5 to 17 has been diagnosed with attention deficit hyperactivity disorder (ADHD), according to the latest government statistics.
    • “The data from the National Health Interview Survey covers the years 2020 through 2022 and came from in-person or phone interviews involving a representative sample of American homes.
    • “It found that 11.3% of school-age children have been diagnosed with ADHD, with boys more likely to have this diagnosis (14.5%) than girls (8%), according to report authors Cynthia Reuben and Nazik Elgaddal, of the National Center for Health Statistics (NCHS).
    • “ADHD is diagnosed more often among white children (13.4%) than Black youngsters (10.8%) or Hispanic (8.9%) kids, the survey also showed. 
    • “Family income seemed to matter, too:  As income levels rose, the rate of child ADHD diagnoses declined.”
  • WTW, an actuarial consulting firm, offers insights on hepatitis C, HPV vaccine and value based insurance design.

From the U.S. healthcare business front,

  • STAT News reports,
    • “The last decade has seen billions of dollars flow into digital health companies that promise to improve outcomes for the 38 million Americans living with type 2 diabetes. Their products aren’t cheap, but in the long term, they pitch to health plans and employers that these digital tools will help cut health care costs by preventing serious complications like amputation and kidney failure.
    • “A systematic review by the Peterson Health Technology Institute found, though, that digital tools used to manage diabetes with the help of finger-stick blood glucose readings don’t result in clinically meaningful improvements over standard care. As a result, they don’t reduce health care spending — they drive it up.
    • “Most of the solutions in this category do not deliver clinical benefits that justify their cost,” Caroline Pearson, executive director of the institute, told STAT. Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products.”
  • Plan Sponsor notes,
    • “In the face of rising health care expenditures and out-of-pocket spending, average health savings account balances have also steadily increased since the COVID-19 pandemic, according to new data from the Employee Benefit Research Institute.
    • “The average HSA balance rose to $4,418 at the end of 2022 from $2,711 at the start of the year, the most recent data available in EBRI’s database, given that participants can still contribute to 2023 HSAs until taxes are due in April.
    • “Jake Spiegel, a research associate at EBRI, says he sees this trend continuing in 2023 and into the start of 2024 as well.
    • “EBRI’s analysis revealed two predominant factors associated with higher average account balances. The first was that age is strongly associated with higher HSA balances: the older the accountholder, the higher the average balance.”
  • Beckers Hospital Review lets us know,
    • “Change Healthcare said it has reinstated Amazon cloud services for two of its platforms a month into a cyberattack against the company.
    • “The UnitedHealth Group and Optum subsidiary said March 20 it restored Amazon Web Services from backups for Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange. Change said it rebuilt authentication services for the solutions on a new network with the help of cybersecurity firms Palo Alto Networks and Mandiant, a Google subsidiary. The company said it is also testing the security of the external-facing parts of those applications.”
  • Per the Society for Human Resource Management,
    • “Employees are experiencing more mental health struggles and overall negative feelings about their work, underscoring an “urgent need” for employers to take more aggressive measures to help with their benefits offerings.
    • “Employees are now more likely to experience negative feelings at work, including stress (12 percent more likely) and burnout (17 percent more likely) than they were pre-pandemic (2019), according to new data from MetLife. Employees are also 51 percent more likely to feel depressed at work than they were pre-pandemic as they face what the insurer calls a “complex macro environment and permacrisis state”—a state which has included the pandemic, persistent high inflation, international turmoil and war, and more.
    • “Those are among the findings in MetLife’s 22nd annual U.S. Employee Benefit Trends Study, released March 18—data indicating that employers may have to revisit benefits offerings to not only support employees, but retain them.”
  • HR Dive explains “How menopausal and other reproductive health benefits can help retain women” and “Data shows that fertility treatments are extremely valuable to workers who need them. Here’s why one people officer is working on integrating them.”
  • STAT News relates,
    • “Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company’s Covid-19 vaccine partner, is now dealing with investor malaise of its own.
    • “Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech’s cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.
    • “Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.”
  • Per Healthcare Dive,
    • “Walgreens-backed VillageMD sold 11 locations in Rhode Island to Boston-based medical group management firm Arches Medical Partners for an undisclosed sum, Arches said Wednesday.
    • “The practices, which include about 75,000 patients, joined Arches on March 2, according to VillageMD’s website. 
    • “The deal follows VillageMD clinic closures. The primary care chain recently exited Florida — once one of chain’s largest markets — and plans to withdraw from its home state in Illinois next month.”

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Maddy Weiss on Unsplash

Happy First Day of Spring!

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers who are finishing writing six annual spending bills have resolved a last-minute roadblock over border funding, setting the stage for Congress to review and approve the legislation on a tight timeline that could take them to the brink of a partial government shutdown this weekend. 
    • “Congressional negotiators late Monday reached a deal on the provisions within the Department of Homeland Security’s funding bill. That bill got caught in an 11th-hour tangle with the White House over border spending, which has become a top issue in many swing states during the 2024 presidential-election year.
    • “In a statement Tuesday morning, Speaker Mike Johnson (R., La.) said an agreement has been reached on the Homeland Security funds, and House and Senate committees have begun drafting bill text to be “prepared for release and consideration by the full House and Senate as soon as possible.”
    • “President Biden said Tuesday that a path on the remaining funding legislation had been finalized and he would sign the measure immediately when it gets to his desk.”
  • Per a House Budget Committee press release,
    • “Today, the House of Representatives advanced House Budget Committee legislation, H.R. 766, the Dr. Michael C. Burgess Preventative Health Savings Act (PHSA), to the Senate by a voice vote. 
    • “The historic accomplishment marks the first time in history that a bipartisan bill with sole Budget Committee jurisdiction has been brought to the Floor under a suspension of the House rules. * * *
    • “One of the major barriers to deploying modernized and innovative policies that would unequivocally curb the cost of health care is the antiquated process used for calculating congressional cost estimates on proposed health care legislation.
    • “Congressional scorekeepers have traditionally focused solely only on the short-term valuation of a policy rather than capturing the long-term economic impact.
    • “But today, with passage of H.R. 766, that changes. This bill seeks to improve the methodology of Congress’ broken budgetary process by providing policymakers with a more accurate cost estimate of the long-term cost savings from preventive health care policies.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new voluntary model that empowers primary care providers in eligible Accountable Care Organizations (ACOs) to treat people with Medicare using innovative, team-based, person-centered proactive care. A key part of the Biden-Harris Administration’s efforts to further promote competition in health care, the ACO Primary Care Flex Model (ACO PC Flex Model) will provide a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs) to ACOs. The advanced shared savings payments provide ACOs with needed resources and flexibility to cover costs associated with forming an ACO (where relevant) and administrative costs for required model activities. PPCPs will be distributed by ACOs to primary care practices, giving them improved resources and flexibility to provide care that best suits individuals’ needs.” * * *
    • “The ACO PC Flex Model is a five-year voluntary model that will begin on January 1, 2025. CMS is planning to select approximately 130 ACOs to participate in the model. Organizations interested in participating must first apply — either as new ACOs or renewing ACOs — to the Shared Savings Program. Shared Savings Program Applications are open May 20, 2024 – June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is planned to be released in the second quarter of 2024.
    • “For Frequently Asked Questions about the Primary Care Flex Model, please visit: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary-care-flex-model/faqs.
    • “For a fact sheet on the model, please visit: https://www.cms.gov/files/document/aco-pc-flex-fs.pdf – PDF.”
  • Yesterday, HHS’s Office for Civil Rights offered guidance to HIPAA covered entities and business associates about their use of online tracking technologies.
    • “Compliance with the Security Rule helps lower the risk of unauthorized access to ePHI collected through a regulated entity’s website or mobile app that could lead to harm to individuals. Therefore, OCR is prioritizing compliance with the HIPAA Security Rule in investigations into the use of online tracking technologies. OCR’s principal interest in this area is ensuring that regulated entities have identified, assessed, and mitigated the risks to ePHI when using online tracking technologies and have implemented the Security Rule requirements to ensure the confidentiality, integrity, and availability of ePHI. OCR investigations are fact-specific and may involve the review of technical information regarding a regulated entity’s use of any tracking technologies. OCR considers all of the available evidence in determining compliance and remedies for potential noncompliance.”
  • The U.S. Preventive Services Task Force issued the following final recommendation today:
    • “For children and adolescents younger than 18 years without signs and symptoms of or known exposure to maltreatment: The evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. [Grade I]”
  • Beckers Payer Issues discusses what fifteen insurers and trade associations explored with Biden Administration officials yesterday about the Change Healthcare situation.
    • During the meeting, stakeholders discussed how progress has been made in reestablishing claims processing systems, though small, rural and safety-net providers specifically are still reporting issues with cash flow.
    • Many healthcare organizations will require third-party certification of Change’s cybersecurity before reconnecting to its systems, in which UnitedHealth was urged to provide a timeframe around. Payers were also asked to analyze their internal data to determine which providers need more support and to engage with them directly.
    • According to Reuters, payers said they would accelerate payments to Medicare and Medicaid providers, along with providing loans to Medicaid providers.”
  • Here is a link to the HHS readout from this meeting.
  • The U.S. Postal Service reminded its retirees with Part A only about the opportunity to enroll for Medicare Part B with no late enrollment penalty during a special enrollment period beginning April 1, 2024. The Postal Service is picking up the late enrollment penalty cost. This is a good deal.
    • “The one-time PSHB SEP is from April 1, 2024, to Sept. 30, 2024. Individuals eligible for the PSHB SEP will receive notification by U.S. Mail™ in March 2024.
    • “All required information must be returned in the envelope provided and postmarked by Sept. 30, 2024.”
  • The Food and Drug Administration announced,
    • “On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 
    • “Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  
    • “Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.” 

From the public health and medical research front,

  • MedPage Today informs us,
    • “Investigation of an early signal for stroke associated with COVID-19 bivalent vaccines turned into suspicion of high-dose or adjuvanted flu shots instead, based on a large U.S. population-based study.
    • “When researchers inspected a large Medicare database, they found no evidence of a significantly elevated risk for stroke at 1-21 days or 22-42 days after vaccination with either of the mRNA COVID vaccines distributed for the 2022-2023 respiratory season when compared with the 43-90 day control window, reported researchers led by Yun Lu, PhD, a statistician of the FDA in Silver Spring, Maryland.
    • “There was a significant excess of nonhemorrhagic stroke for people with concomitant administration of Pfizer-BioNTech’s bivalent vaccine plus a high-dose or adjuvanted influenza vaccine during the 22-42 days risk window (risk difference of 3.13 out of 100,000 doses); and a significant excess of transient ischemic attack for people with concomitant administration of Moderna’s bivalent COVID vaccine plus a high-dose or adjuvanted influenza vaccine during the 1-21 days risk window (risk difference of 3.33 out of 100,000 doses).
    • “But the researchers found that people with administration of a high-dose or adjuvanted influenza vaccine alone (without concomitant COVID vaccination) had an elevated risk for the combined outcome of nonhemorrhagic stroke or transient ischemic attack in both the 1-21 days risk window (risk difference of 1.65 per 100,000 doses) and 22-42 days risk window (risk difference of 1.60 per 100,000 doses).
    • “This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” the investigators reported in JAMA.”
  • Medscape lets us know,
    • “The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes. 
    • “The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithmthat was originally developed through patient-led, open-source initiatives.
    • “The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News. 
    • “It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained. “

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Elevance Health has inked a deal to acquire Kroger Specialty Pharmacy.
    • “The grocery chain announced Monday that an agreement is in place, saying it’s expected to close in the back half of 2024 pending regulatory approvals. Elevance intends to add Kroger Specialty Pharmacy to its CarelonRx business, which houses its pharmacy benefit management services.
    • “Financial terms of the sale were not disclosed.”
  • Per BioPharma Dive,
    • “AstraZeneca is the latest large pharmaceutical company to make a sizable bet on radiopharmaceutical drugs for cancer, agreeing on Tuesday to acquire longtime biotechnology partner Fusion Pharmaceuticals in a deal worth up to $2.4 billion.
    • “AstraZeneca will acquire all of Fusion’s shares for $21 apiece, or about $2 billion. The British drugmaker could add another $3 per share via a financial instrument known as a “contingent value right” if Fusion meets an unspecified regulatory milestone. Should Fusion hit that mark, the buyout would be worth $2.4 billion.” 
  • Beckers Health IT offers six takeaways from last month’s HIMSS conference.

Happy Pi Day!

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, Rx coverage–
Photo by Taso Katsionis on Unsplash

From Washington, DC

  • The bipartisan leadership of the Senate Finance Committee are pressing Congress for prescription benefit manager reform.
    • Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo R-Idaho, today renewed their call for the passage of their bipartisan legislation to crack down on pharmacy benefit managers (PBMs) and their shadowy tactics that are driving up the cost of prescription drugs and forcing pharmacies across the country to close their doors.
    • Ahead of a press conference this morning where Senators Wyden and Crapo were joined by pharmacy and patient advocates to press for PBM reform, the Senators sent a letter to their Finance Committee colleagues reaffirming their commitment to getting their legislation across the finish line as soon as possible this Congress.
  • FEHBlog observation — Read this Brookings Institution article to understand why the Senator’s position may be overwrought.
  • STAT News reports,
    • “Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.
    • “Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law, the Food and Drug Administration’s move could give doctors an avenue to prescribe the medications to some Medicare patients.
    • “Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.
    • “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.”
  • MedPage Today tells us,
    • “The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
    • “A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
    • “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
    • “A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
    • “According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.”
  • Healthcare IT News fills us in on an interesting conversation between the Deputy Coordinator of Health Information Technology and the CDC Director at the HIMSS conference in Orlando.

From the public health and medical research front,

  • The New York Times reports,
    • “Teen pregnancy increases the chances that a young woman will drop out of school and struggle with poverty, research has shown. Teenagers are also more likely to develop serious medical complications during pregnancy.
    • “Now a large study in Canada reports another disturbing finding: Women who were pregnant as teenagers are more likely to diebefore their 31st birthday. The trend was observed among women who had carried teen pregnancies to term, as well as among those who had miscarried.
    • “The younger the person was when they became pregnant, the greater their risk was of premature death,” said Dr. Joel G. Ray, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto and the first author of the study. It was published in JAMA Network Open on Thursday.
    • “Some people will argue that we shouldn’t be judgmental about this, but I think we’ve always known intuitively that there’s an age that is too young for pregnancy,” he added.
  • The Washington Posts informs us,
    • “A new study calls into question the extent of the maternal mortality crisis in the United States, which has long posted a disproportionately high rate of maternal deaths compared with peer nations.
    • “Data classification errors have inflated U.S. maternal death rates for two decades, according to the study published Wednesday in the American Journal of Obstetrics & Gynecology. Instead of the maternal death rate more than doubling since 2002, it has remained flat, researchers found.
    • “There has been a lot of alarm and apprehension surrounding the fact that some of these reports show a threefold increase in maternal mortality, and that is not what we found. We found low and stable rates,” said K.S. Joseph, the study’s lead author and professor in the departments of obstetrics and gynecology and the School of Population and Public Health at the University of British Columbia in Vancouver. * * *
    • “Some experts say the study’s biggest takeaway is the persistent racial disparities, with many pregnant Black people experiencing more medical complications involving Caesarean sections, postpartum hemorrhaging and preterm births. However the data is calculated, the pattern remains the same, said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital as well as a fellow of the American College of Obstetricians and Gynecologists.
    • “We should be targeting a lot of our public outreach to focus on conditions that are affecting patients of color while they’re pregnant,” said Denny, who was not involved with the study.”

From the cybersecurity front,

  • UHC updated its Change Healthcare cyberattack response website today.
    • “Palo Alto Networks Unit 42 experts are on the ground, collaborating diligently with UnitedHealth and their partners to restore operations and ensure a swift and secure resolution following the recent disruption. To date we have reviewed and protected a large majority of infrastructure, including the server and application space, and assisted in bringing critical services back online that allowed for more than 9 million prescriptions to be filled.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services March 13 released additional information on the Medicare accelerated and advance payments that hospitals, physicians and others impacted by the Change Healthcare cyberattack may apply for through their Medicare Administrative Contractors. According to CMS, the MACs aim to review requests and notify most providers/suppliers of the outcome of their request within five business days of receipt.
  • Aetna provides a good example of the information that other carriers are sharing with their network providers and members about the Change Healthcare situation.

From the U.S. healthcare business front,

  • EBRI offers new research about health savings accounts.
    • “HSA balances continued to increase over the course of the year, despite higher spending on health care. Continuing a trend observed post-COVID-19 pandemic, patient spending on health care increased in 2022. Still, average end-of-year HSA balances were higher than average beginning-of-year balances. Average balances increased at an even faster rate in 2022, conditional on those accounts receiving either an employee or employer contribution over the course of the year. 
    • “Accounts that received an employer contribution saw higher total contributions and were more likely to invest. Employers seeking to help their workers engage with their HSAs may find employer contributions to be a useful tool, as accountholders who received an employer contribution on their behalf had higher average total contributions and were more likely to invest. Our analysis indicates, however, that these accountholders were also more likely to take more frequent and larger distributions. 
    • “Most accountholders took a distribution in 2022. More than half of the HSAs in EBRI’s database saw a distribution in 2022, and the average distribution was $1,868. 
    • “Relatively few HSAs are invested. One of the largest advantages HSAs offer is the ability to invest assets within the account. However, our analysis reveals that only 13% of accountholders invested their HSAs in assets other than cash. 
    • “Age and tenure play a major role in HSA utilization. Consistent with previous findings, accountholder age — as well as accountholder tenure — is closely related to average balances, contributions, and distributions, as well as the propensity to invest. On average, older accountholders contributed more to their HSAs, had higher balances, more frequently took distributions, and had a higher likelihood of investing at least some portion of their HSA in assets other than cash.”
  • McKinsey and Co. shares its report on the future of Medicare Advantage.
    • “The Medicare Advantage program is undergoing its biggest shifts in more than two decades. Payers can take steps now to mount a strategic, agile response as the changes unfold.”

 

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Monday Roundup

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%, 4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia — An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction. 
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement. 

Weekend Update

David Ermer–CDC, CMS, Congress, Cybersecurity, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • “Reported on Friday, March 8th, 2024.“
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Federal News Network reports,
    • “The House passed a $460 billion package of spending bills Wednesday that would keep money flowing to key federal agencies through the remainder of the budget year. The Senate is expected to take up the legislation before a midnight Friday shutdown deadline.
    • “Lawmakers are negotiating a second package of six bills, including defense, in an effort to have all federal agencies fully funded before a March 22 deadline. In the end, total discretionary spending set by Congress is expected to come in at about $1.66 trillion for the full entire year. 
    • “A significant number of House Republicans have lined up in opposition to the spending packages, forcing House Speaker Mike Johnson, R-La., to use an expedited process to bring the bill up for a vote. That process requires two-thirds of the House to vote for the measure for it to pass.
    • “The House passed the measure by a vote of 339-85.”
  • The American Hospital Association News adds,
    • “The House March 5 voted 382-12 to pass the AHA-supported Preventing Maternal Deaths Reauthorization Act (H.R. 3838), bipartisan legislation that would reauthorize federal support for state-based committees that review pregnancy-related deaths to identify causes and make recommendations to prevent future mortalities. Passed by the House Energy and Commerce Committee last July, the bill also would require the Centers for Disease Control and Prevention to work with the Health Resources and Services Administration to disseminate best practices to prevent maternal mortality to hospitals and other health care providers.”
  • Per an HHS press release,
    • “Today, in support of President Biden’s Unity Agenda, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for HRSA’s Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Opioid use disorder is particularly concerning in rural communities and accessing treatment can be challenging due to geographic isolation, transportation barriers, and limited substance use disorder providers. This week, HRSA hosted more than 800 rural community leaders working at the grassroots level to build their communities’ capacity to turn the tide of the opioid epidemic. * * *
    • “Applications will be accepted through May 6, 2024, and the funding opportunity is posted at: https://grants.gov/search-results-detail/349409.
    • “To learn more about other programs under the Rural Communities Opioid Response Program, visit https://www.hrsa.gov/rural-health/opioid-response.”
  • Govexec tells us,
    • “Coming on the heels of debuting its new public-facing repository of high-ranking federal officials, the Office of Personnel Management released guidance last week outlining how agencies should report data to the website and how often. 
    • “The March 1 guidance details how agencies will comply with the Periodically Listing Updates to Management (PLUM) Act, which moved OPM away from maintaining the quadrennial Plum Book after this year to an annually updated website that offers information about senior agency leaders, Senior Executive Service members and other top or non-competitively appointed officials. 
    • “OPM officials launched the new website in January, phasing out the physical Plum Book that dated back to President Eisenhower’s 1952 request for a list of every position his administration would have to fill. 
    • “At the time of its launch, the PLUM reporting website possessed the names, roles and pay levels of more than 8,000 executives, with plans to grow to 10,000 with subsequent updates.”
  • The Hill notes,
    • “Alabama Gov. Kay Ivey (R) signed a bill Wednesday protecting in vitro fertilization (IVF) providers from the state Supreme Court’s recent ruling that frozen embryos are to be considered children. 
    • “The legislation, titled SB 159, will shield IVF providers from lawsuit or criminal charges over the “death or damage to an embryo,” during the IVF process. The bill passed by both the state Senate and House shortly before heading to Ivey’s desk Wednesday night.” 

From the FEHB front,

  • An expert, writing in Govexec, offers tips for federal retirees on making the decision whether or not to enroll in Medicare Part B. FEHBlog tip — Income adjusted Medicare Part B premiums usually are temporary while the Medicare Part B late enrollment penalty is forever.
  • Reg Jones, writing in FedWeek, discusses “Your Federal Benefits in Divorce.”

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

  • HR Morning offers employers guidance on how to improve employee health.
  • The National Institutes of Health announced,
    • “More than 70% of American Indian young adults aged 20-39 and 50% of American Indian teens have cholesterol levels or elevated fat in the blood that put them at risk for cardiovascular disease, suggests a study supported by the National Institutes of Health. In some cases, these levels — specifically high low-density lipoprotein (LDL) cholesterol, often thought of as “bad cholesterol,” — were linked to plaque buildup and cardiovascular events, such as heart attack and stroke.
    • “The findings, published in the Journal of the American Heart Association, came from a 19-year-review of the Strong Heart Family Study, part of the Strong Heart Study — the largest study of cardiovascular health outcomes and risk factors among American Indian adults. Researchers followed more than 1,400 participants, ages 15-39, between 2001-2003 and 2020. At the beginning of the study, 55% of participants ages 15-19 had abnormal cholesterol levels, as did 74% of those ages 20-29, and 78% of those ages 30-39.”
  • and
    • “Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression. The outcomes reported today follow planned ART interruptions once the children met predefined virological and immunological criteria.”
    • “These findings are clear evidence that very early treatment enables unique features of the neonatal immune system to limit HIV reservoir development, which increases the prospect of HIV remission,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “The promising signals from this study are a beacon for future HIV remission science and underscore the indispensable roles of the global network of clinicians and study staff who implement pediatric HIV research with the utmost care.”
  • and
    • “Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
    • “The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
  • MedPage Today lets us know,
    • “Rates of emergency surgery, serious complications, and hospital readmissions were higher among Medicare patients living in primary care shortage areas, according to a cross-sectional retrospective cohort study of data from 2015 to 2019.
    • “Medicare beneficiaries living in areas with the most severe primary care shortages had higher rates of three types of emergency surgeries compared with those living in areas with the least severe shortages (37.8% vs 29.9%; risk ratio [RR] 1.26, 95% CI 1.17-1.37, P<0.001), reported Sara Schaefer, MD, of the University of Michigan in Ann Arbor, and co-authors.
    • “Those in areas with the most severe shortages were also more likely to have serious complications (14.9% vs 11.7%; adjusted RR 1.27, 95% CI 1.12-1.44, P<0.001) and readmissions (15.7% vs 13.5%; adjusted RR 1.16, 95% CI 1.01-1.33, P=0.03), they noted in Health Affairs.
    • “However, beneficiaries in areas with the most and least severe shortages had similar rates of 30-day mortality (5.6% vs 4.8%; adjusted RR 1.17, 95% CI 0.93-1.47, P=0.17) and any complications (25.9% vs 24.5%; adjusted RR 1.05, 95% CI 0.97-1.15, P=0.21).
    • “Schaefer told MedPage Today that what surprised her most about the study was the strength of the association for the primary endpoint. Across multiple iterations of analyses, the trend remained consistent, she said.”
  • Health Day relates that according to “researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.”
    • “Sugary and diet drinks both appear to increase the risk of atrial fibrillation.
    • “Two liters weekly of diet drinks increased risk by 20%, and sugary drinks raised risk by 10%.
    • “Conversely, one liter weekly of unsweetened fruit or vegetable juice lowered risk by 8%.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
    • “Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
    • “The healthcare system’s measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”
  • Beckers Hospital Review points out four U.S. hospitals with uncertain futures.
  • Beckers Hospital Review also reports,
    • “Mark Cuban Cost Plus Drug Co. plans to begin manufacturing epinephrine and norepinephrine this week at its 22,000-square-foot drug facility in Dallas, Mr. Cuban confirmed to Becker’s on March 5. 
    • “The $11 million drug manufacturing plant, which originally planned to start operating in late 2022, will focus on producing injectable drugs that often fall into shortages. 
    • “Epinephrine is an emergency treatment for severe allergy reactions, and norepinephrine is a blood pressure medication. Injection solutions of the former have been in unsteady supply since at least 2012. Neither the FDA nor the American Society of Health-System Pharmacists list norepinephrine as a current shortage. 
    • “Next on the docket are pediatric oncology drugs, according to Fortune and Politico.” 
  • Beckers Payer Issues calls attention to the fact that
    • “Twenty-six states [listed in the BPI article] now have more than half of their Medicare enrollees in Medicare Advantage plans, according to a March 5 report from Chartis, a healthcare advisory services firm. 
    • “Nationwide, half of Medicare-eligible beneficiaries are now enrolled in Medicare Advantage plans.”