From Washington, DC

• BioPharma Dive reports
  • The U.S. House of Representatives voted Monday to approve legislation that would restrict U.S. companies from working with five China-based biotechnology firms on clinical development, research and manufacturing, in an attempt to secure the pharmaceutical supply chain.
  • The Biosecure Act passed 306-81 under a procedure used to pass relatively noncontroversial legislation. It was left out of a large Department of Defense bill that cleared the House in June, but may yet need to be included in a Senate version of that defense bill for it win support in that chamber.
  • The legislation would prohibit the federal government from contracting with the five “companies of concern” or any biotech that has a contract with those companies. Drugmakers with current contracts would have until 2032 to allow those deals to expire before being subject to the law.

• Roll Call and Govexec bring us up to date on FY 2025 appropriations measures under consideration on Capitol Hill.

• Govexec tells us,
  • “A bipartisan pair of lawmakers on Tuesday filed a discharge petition seeking to force a vote on the House floor on a measure that would eliminate a pair of controversial tax rules that reduce the retirement benefits of some ex-government workers.
  • “Reps. Abigail Spanberger, D-Va., and Garret Graves, R-La., are the lead sponsors of the Social Security Fairness Act (H.R. 82), a measure introduced last year that would eliminate Social Security’s windfall elimination provision and government pension offset.” * * *
  • “Though the bill has widespread support in Congress among both parties—with more than 300 cosponsors in the House alone—the chamber’s leadership has balked at allowing the bill to receive a floor vote. If Spanberger and Graves can secure at least 218 signatures among House lawmakers, they can then force such a vote to take place.”

• FedWeek reminds us,
  • “September 30 is the end of the “special enrollment period” in which Postal Service retirees eligible for Medicare Part B but not currently enrolled in it may elect that coverage without the standard penalty for enrolling more than three months beyond first eligibility, which typically is on turning age 65.” * * *
  • “Further information on the special enrollment period is here.
  • “Meanwhile, the announcement of plans, coverage terms and premium rates in both the FEHB and the PSHB for 2025 is just ahead. That announcement commonly comes in late September or early October, with fuller information provided just ahead of the open season for enrolling or changing current enrollments, which this year will run November 11-December 9.”

• Newfront poses a Q&A,
  • “Question: What steps do employers need to take to ensure their coverage meets the ACA affordability standard in 2025?
  • “Short Answer: The 2025 ACA affordability threshold increases to 9.02%. The easiest way to ensure affordability in 2025 is to meet the federal poverty line affordability safe harbor by offering at least one medical plan option (that provides minimum value) for which the monthly employee-share of the premium for employee-only coverage does not exceed $113.20. Otherwise, employers will need to calculate the applicable affordability threshold under one of the other safe harbor approaches, which are based on employee compensation levels.”

• Per an HHS press release,
  • “The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), recently awarded $68 million in grants for suicide prevention and mental health care programs. Addressing the U.S. mental health crisis and preventing suicide are top priorities of the Biden-Harris Administration and part of President Biden’s Unity Agenda.
  • “Every September we recognize Suicide Prevention Month as a time to raise awareness—to remind those struggling that they are not alone and that there is hope. Many people who have experienced suicidal thoughts are alive today because they got help,” said HHS Secretary Xavier Becerra, “The Biden-Harris Administration is deeply committed to expanding and improving suicide prevention in order to save lives. That is why we launched the 988 Suicide & Crisis Lifeline two years ago and why we continue to invest in suicide prevention programs that help save lives across this country.”

• The Census Bureau posted its report with 2023 statistics on health insurance coverage in the United States based on information collected in the Current Population Survey Annual Social and Economic Supplement (CPS ASEC).
  • “Of the subtypes of health insurance coverage, employment-based insurance was the most common, covering 53.7 percent of the population for some or all of the calendar year, followed by Medicaid (18.9 percent), Medicare (18.9 percent), direct-purchase coverage (10.2 percent), TRICARE (2.6 percent), and VA and CHAMPVA coverage (1.0 percent).
  • “While the private coverage rate was statistically unchanged between 2022 and 2023, the employment-based coverage rate declined by 0.7 percentage points to 53.7 percent in 2023. At the same time, the rate of direct-purchase coverage increased by 0.3 percentage points to 10.2 percent in 2023.”

From the public health and medical research front,

• Modern Healthcare reports,
  • “Cost, wait times, transportation problems and negative interactions with healthcare professionals are driving U.S. women to delay medical care or skip it altogether, according to a recent Deloitte survey.
  • “Half of the approximately 1,000 women who responded to the consultancy’s 2024 Health Care Consumer Survey said they had forgone care in the past year, compared with 37% of men, Deloitte said in a report Tuesday.
  • “Deloitte paired the results of its survey — which asked a representative sample of roughly 2,000 people in February 2024 about how everyone in the country could have quality medical care — with an analysis of claims data. It found that although women require on average almost 10% more health services than men, they’re about 35% more likely to say they’ve skipped or delayed care.”
    
• JD Supra offers “5 Tips for Employers to Prepare for Cold, Flu, and COVID Season.”

• The Centers for Disease Control and Prevention suggest five actions that communities can take to reduce suicides.

• Per National Institutes of Health press releases,
  • “A scientific team supported by the National Institutes of Health (NIH) has created a preclinical blood test to identify adults most likely to develop severe respiratory conditions, including chronic obstructive pulmonary disease (COPD). The blood test analyzes 32 proteins that scientists determined accurately predicted an adult with an increased likelihood for requiring medical care for or dying from severe respiratory illness. The risk score was based on lung health data collected from nearly 2,500 U.S. adults over a 30-year period. The findings were published in the American Journal of Respiratory and Critical Care Medicine(link is external).
  • “We are still not ready for this test to be used in practice, but it’s a promising advance,” said James P. Kiley, Ph.D., director of the Division of Lung Diseases at NIH’s National Heart, Lung, and Blood Institute (NHLBI), which funded the study. “It consolidates insights from decades of breathing tests and medical evaluations into a single tool that has the potential to identify patients at risk for severe disease and complications.”
• and
  • “Providing optional syphilis tests to most people seeking care at a large emergency department led to a dramatic increase in syphilis screening and diagnosis, according to a National Institutes of Health (NIH)-supported study of nearly 300,000 emergency department encounters in Chicago. Most people diagnosed had no symptoms, which suggests that symptom-based testing strategies alone could miss opportunities to diagnose and treat people with syphilis. The results were published today in the journal Open Forum Infectious Diseases.
  • “The Centers for Disease Control and Prevention (CDC) estimates that adult and congenital syphilis cases increased by 80% and 183% respectively between 2018 and 2022. Improved syphilis diagnosis strategies will be essential for reaching populations such as pregnant women and people with limited access to health care. The optimal model for syphilis screening has not been identified, particularly for preventing congenital syphilis. Previous literature supports targeted emergency department syphilis screenings based on clinical factors such as active symptoms or pregnancy. However, the screening criteria used in those models would not capture most people whose syphilis is asymptomatic.”

• Here is a link to NIH’s Research Matters report covering “Deep brain stimulation for Parkinson’s | Brain-computer interface for speech | Glucose metabolism and Alzheimer’s disease.”

• Per STAT News,
  • “The first late-stage trial of a GLP-1 drug in young children with obesity showed the treatment helped lower body mass index. But the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age.”

• Per Medscape
  • “Sustained participation in a community-based structured exercise program is linked to a reduced risk for all-cause hospitalization among older adults, but the benefits varied by gender {favoring women], according to a new study.”

• Ruh roh. Bloomberg Prognosis lets us know,
  • “I [the reporter] was exposed to Covid at a family get-together in upstate New York last month. Two days later, I woke up feeling awful — sniffles, fatigue and fever. So I swabbed both nostrils with the last Covid test in our cabinet. 
  • “To my great surprise, it was negative, and I went back to sleep. When I tested again two days later, it turned positive in seconds. I started to wonder: Are home Covid tests bad at detecting the latest variants?
  • “The short answer is no, the doctors I spoke with told me. But that answer comes with a big caveat. It turns out the way the immune system interacts with the virus these days means home tests may not turn positive until several days after you get sick.”

• More ruh roh. The New York Times reports,
  • “Two years before a deadly listeria outbreak [earlier this year], U.S. inspectors warned that conditions at a Boar’s Head plant posed an “imminent threat” to public health, citing extensive rust, deli meats exposed to wet ceilings, green mold and holes in the walls.
  • ‘But the U.S. Agriculture Department did not impose strict measures on the plant, in Jarratt, Va., which could have ranged from a warning letter to a suspension of operations.
  • “Since then, other inspections found that many of the problems persisted, but again, the plant continued to process tons of beef and pork products, including liverwurst.”

From the U.S. healthcare business front,

• Modern Healthcare reports,
  • “More providers are opting out of contracts with Medicare Advantage plans as national insurers reconfigure their networks, leaving patients in limbo.
  • “Medicare Advantage enrollment and profitability surged in recent years as a growing number of seniors sought plans with minimal copays and extra benefits not offered in traditional Medicare. However, Medicare Advantage enrollment growth has slowed and insurance companies’ earnings per member have declined over the past year as insurers grapple with stiffer competition, higher medical costs and utilization, lower reimbursement rates and stricter regulatory oversight.” * * *
  • “This is just the start of insurers’ squeeze on Medicare Advantage markets and provider contracts, the effects of which will grow as Medicare Advantage enrollment is expected to account for about 60% of all Medicare membership by 2030, consultants, analysts and policy experts said.
  • “This is the first year that MA plans have really hammered hospitals, and I think it will get uglier,” industry consultant Paul Keckley said.
  • “Health systems have walked away from in-network agreements or looked to scale up as a buffer and negotiating tool.”
• and
  • “The American Medical Association released its updated list of Current Procedural Terminology codes for 2025, adding 270 new universal codes used for billing healthcare services and reimbursing providers.
  • “The organization announced 420 updates to its list Tuesday, with several revisions and additions for genetic testing, digital health services like remote patient monitoring and care involving artificial intelligence.”

• Even more ruh roh. The American Hospital Association News complains,
  • “Hospitals and health systems are seeing significant increases in administrative costs, including due to burdensome practices by commercial insurers that often delay and deny care for patients, according to a new report released Sept. 10 by the AHA. 
  • “Many hospitals and health systems are forced to dedicate staff and clinical resources to appeal and overturn inappropriate denials, which alone can cost billions of dollars every year,” the report notes. 
  • “Among other findings, the report highlights recent data from Strata Decision Technology showing that administrative costs alone account for more than 40% of total expenses hospitals incur in delivering care to patients. In addition, between 2022 and 2023, care denials increased an average of 20.2% and 55.7% for commercial and Medicare Advantage claims, respectively.” 

• Per Fierce Healthcare,
  • “UnitedHealth Group’s Optum Rx will join its peers in the big three pharmacy benefit managers by pulling Humira from some of its preferred formularies, according to a report from Reuters.
  • “Instead, it will recommend a cheaper biosimilar as the preferred option beginning Jan. 1, 2025, according to the article. Amgen’s Amjevita biosimilar will be among the options.
  • “CVS Health’s Caremark announced similar steps in April, and Cigna’s Express Scripts unit followed suit in August. Prescriptions for Sandoz’s Hyrimoz biosimilar spiked after CVS removed Humira from its major commercial formularies, according to a report in Stat.
  • “Reuters reported that UnitedHealth will continue to offer Humira coverage until the biosimilars are awarded an interchangeable designation from the Food and Drug Administration, which is expected in 2025.”