From Washington, DC,

• Politico reports,
  • “A bipartisan group of nearly two dozen senators huddled Monday night to work out an 11th-hour health care deal to extend Affordable Care Act insurance subsidies set to expire at the end of this month.
  • “At a meeting convened by Sens. Susan Collins (R-Maine) and Bernie Moreno(R-Ohio), the senators discussed a two-year extension of the Obamacare tax credits that would be coupled with a new income eligibility cap and fraud prevention language.

• The Wall Street Journal adds,
  • “Senate Majority Leader John Thune (R., S.D.) said Congress won’t be able to extend federal health-insurance subsidies before leaving for the holidays, ending hopes for a last-minute deal and punting any possible fix into the new year.
  • “We’re not going to pass anything by the end of this week, but I do think there’s a potential pathway in January,” Thune said at a press conference on Tuesday. Lawmakers are expected to depart Washington before the weekend and won’t return until Jan. 5.” * * *
  • “House Republicans still are expected to pass a GOP healthcare bill on Wednesday that would expand access to association health plans, which generally allow small employers to band together and provide health insurance, and appropriate money to fund the cost-sharing reductions that reduce out-of-pocket spending for lower-income ACA enrollees. It doesn’t include any ACA extensions or the health savings accounts favored by many Republicans. 
  • “The Congressional Budget Office said the bill would reduce the federal deficit by $35.6 billion over a decade, but it would also reduce the number of people with health insurance by an average of 100,000 a year.” 

• OPM Director Scott Kupor added a post about the new U.S. Tech Force to his Secrets of OPM blog today.

• Federal News Network adds,
  • “Agencies will soon see a more streamlined process for potentially offering higher-value bonuses to federal employees who are being hired or relocated.
  • “A new final rule from the Office of Personnel Management on Tuesday seeks to reduce “administrative burden” and “increase efficiency” in the process for approving recruitment and relocation incentives. The changes come after OPM first proposed regulations in November 2023.
  • “In practice, OPM’s changes will shift the transactional work of approving waivers for larger bonuses off of OPM’s plate, and instead make it the responsibility of individual agencies. The goal is make the process for offering pay incentives easier, and in theory free up time for OPM to focus on other priorities, according to the final rule.”

• HHS Assistant Secretary for Technology Steve Posnak remarks in his agency’s HealthBuzz blog
  • In July the Centers for Medicare & Medicaid Services (CMS) launched an ambitious Health Technology Ecosystem pledge program. The groundswell of energy and enthusiasm for the program has been remarkable, and we’re glad to be their partner. CMS established several pledge categories associated with aspirational criteria included within its CMS Interoperability Framework. This [HealthBuzz] post looks specifically at the similarities and differences between the Trusted Exchange Framework and Common Agreement™ (TEFCA™) and the “CMS-Aligned Network” pledge category.

• Per an HHS news release,
  • “The U.S. Department of Health and Human Services (HHS) today announced the appointment of Harvey Risch, M.D., Ph.D., as chairman of the President’s Cancer Panel. The panel, part of the National Institutes of Health’s (NIH) National Cancer Institute, is charged with monitoring the development and execution of the activities of the National Cancer Program and reporting to the president on progress, efficacy, and opportunities for improvement in the national effort against cancer. The Panel was established by law through the National Cancer Act of 1971.”

• Per a GAO news release,
  • “Congress created USPS to be financially self-sufficient. However, USPS has lost billions since 2007 as people use mail less and costs increase. As a result, USPS’s financial viability has been on our High Risk list since 2009.
  • “USPS has tried to improve financially by raising prices and making operational changes. Congress also passed legislation to reduce some of USPS’s expenses. More must be done. But USPS hasn’t projected how its changes, like transporting more mail on trucks, may affect its future revenue, expenses, and more. USPS and Congress need these projections to determine what other steps to take. Our recommendation addresses this.”

From the Food and Drug Administration front,

• Biopharma Dive reports,
  • “The Food and Drug Administration on Monday granted a key approval for AstraZeneca and Daiichi Sankyo’s Enhertu, clearing a regimen involving the drug as an initial treatment for HER2-positive breast cancer. 
  • “The approval issued Monday comes well ahead of the FDA’s Jan. 23 decision deadline and greenlights a combination of Enhertu and Roche’s targeted therapy Perjeta for frontline use in people whose metastatic breast cancer is confirmed to be HER2-positive by an FDA-approved test. The clearance is based on results published in the New England Journal of Medicine earlier this year, which showed the Enhertu-Perjeta regimen was more beneficial than the current first-line standard, a combination of chemotherapy and precision drugs that’s known as THP.” 

• MedTech Dive notes,
  • “The Food and Drug Administration received more than 100 comments after seeking responses on how to monitor the real-world performance of artificial intelligence in medical devices. 
  • “The feedback diverged, with patients calling for stronger postmarket reporting and medical groups saying reporting should be the responsibility of manufacturers. Device companies, meanwhile, called for the FDA to use its existing regulatory frameworks instead of introducing new requirements.
  • “The FDA’s emphasis on real-world performance comes as the agency considers how to regulate increasingly complex technologies, such as generative AI, and how to ensure the performance of AI models doesn’t degrade over time.” 

From the public health and medical / Rx research front,

• Per HHS news releases,
  • “The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. Early detection of both conditions allows children to receive FDA-approved therapies at the most effective time, helping to slow disease progression and preserve their quality of life.
  • “As my uncle has said, ‘although children may be the victims of fate, they will not be the victims of our neglect,’” said Secretary Kennedy. “This action honors that principle. Early screening gives every child a fair chance at timely, effective care, and it delivers families the answers and treatment options they deserve—right when they need them most.”
• and
  • “The Centers for Disease Control and Prevention (CDC) today adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.” * * *
  • “The CDC is reviewing ACIP’s secondary recommendation that parents should consult with a health care provider on serology testing to determine whether a subsequent hepatitis B vaccine dose is needed. For infants born to mothers who test positive for hepatitis B or whose status is unknown, the currently recommended birth dose of hepatitis B vaccine and immunoglobulin continues with no change.
  • “The adoption of individual-based decision-making for hepatitis B immunization maintains consistency of coverage through all payment mechanisms, including entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.
  • “Fact Sheet: Hepatitis B Immunization“

• Per MedTech Dive,
  • “The Centers for Medicare and Medicaid Services will reconsider its national coverage determination for transcatheter aortic valve replacement in response to a request from Edwards Lifesciences, according to an agency posting on Monday.
  • “Edwards, in a July letter, asked the agency to reconsider its current policy for TAVR patients who are Medicare beneficiaries to reflect new evidence demonstrating improved outcomes when the valves are used to treat asymptomatic patients. Those patients are currently beyond the scope of Medicare coverage for the treatment.
  • “Analysts expect expanded Medicare coverage to drive further adoption of TAVR. William Blair analyst Brandon Vazquez said one-third of severe aortic stenosis patients are estimated to be asymptomatic. Broader reimbursement could also prompt more hospitals to open TAVR centers, Vazquez said.”

• The New York Times reports,
  • “For a while, it seemed the notion that light drinking was good for the heart had gone by the wayside, debunked by new studies and overshadowed by warnings that alcohol causes cancer.
  • “Now the American Heart Association has revived the idea in a scientific review that is drawing intense criticism, setting off a new round of debate about alcohol consumption.
  • “The paper, which sought to summarize the latest research and was aimed at practicing cardiologists, concluded that light drinking — one to two drinks a day — posed no risk for coronary disease, stroke, sudden death and possibly heart failure, and may even reduce the risk of developing these conditions.
  • “Controversy over the influential organization’s review has been simmering since it was published in the association’s journal Circulation in July.”

• Per Fierce Pharma,
  • “With a second late-stage trial win for its investigational HIV combo in the books, Gilead Sciences is moving full steam ahead toward regulatory filings for the novel HIV regimen.
  • “In Gilead’s Artistry-2 study, the company’s single-tablet regimen of bictegravir and lenacapavir matched up to Gilead’s own megablockbuster HIV medicine Biktarvy when assessing patients’ treatment responses, Gilead said in a Dec. 15 release. The trial enrolled adults with HIV who had achieved virologic suppression on Biktarvy and randomized them 2-1 to either switch to the novel regimen or continue receiving Biktarvy.”

• Per MedPage Today,
  • “More than 70% of patients with advanced triple-negative breast cancer (TNBC) responded to an investigational bispecific antibody targeting PD-L1 and VEGF-A plus chemotherapy, a preliminary study showed.
  • “Overall, 71.8% (61.5% confirmed) of patients had partial responses to either of two dose levels of pumitamig plus nab-paclitaxel (Abraxane), and 23.1% had stable disease, resulting in a disease control rate of 94.9%. Tumor shrinkage occurred in all but five evaluable patients, averaging 42.6% for the entire cohort.”

From the U.S. healthcare business front,

• Fierce Healthcare reports,
  • “With COVID sales falling and patent protections expiring, Pfizer is forecasting its 2026 revenue to be in the range of $59.5 billion to $62.5 billion. The midpoint of the projection ($61 billion) would be a decline from this year’s estimated revenue of $62 billion—which the company reaffirmed on Tuesday. It would also be an additional slide from Pfizer’s 2024 revenue of $63.6 billion.
  • “Built into the 2026 guidance is a $1.5 billion decline in sales of its COVID products—from an estimated $6.5 billion this year to $5 billion in expected sales next year. The company also expects to sustain a $1.5 billion hit from the loss of exclusivity (LOE) of its products.
  • “As those LOEs escalate in the coming years—to $3 billion-plus in 2027 and $6-plus in 2028—the drugmaker said that it doesn’t expect to see growth until 2029.”

• Modern Healthcare relates,
  • “Medline Inc. raised $6.26 billion in the year’s biggest initial public offering, upsizing the deal and pricing the shares near the top of the marketed range.
  • “The company sold 216 million shares Tuesday for $29 each, according to a statement confirming a Bloomberg News report. Medline, which counts Blackstone Inc., Carlyle Group Inc. and Hellman & Friedman among its backers, had marketed 179 million shares for $26 to $30 each.
  • “The pricing gives the company a market value of about $39 billion, based on the number of shares listed in its filings with the U.S. Securities and Exchange Commission.
  • “Medline manufactures and distributes medical supplies such as gloves, gowns and exam tables used by hospitals and doctors. The three private equity firms sealed a $34 billion deal to acquire a majority stake in the company in 2021, in one of the largest leveraged buyouts of all time.” 
• and
  • “City of Hope has opened Orange County’s first hospital exclusively dedicated to cancer care, marking a major milestone in the organization’s commitment to increasing access to advanced cancer treatment and research across the country. 
  • “The cancer specialty hospital, which began seeing patients Dec. 1, sits on City of Hope Orange County’s 72-acre academic campus in Irvine, California, and is connected to City of Hope Orange County Lennar Foundation Cancer Center, which opened in 2022. The opening completes a full continuum of cancer services in the region, enabling patients to access advanced inpatient and outpatient care, clinical trials and surgical oncology services without having to leave the region. Before City of Hope arrived in Orange County, as many as 20% of local cancer patients left the area to receive advanced cancer care, according to the organization. 
  • “We want every person to have options and access to the most skilled teams, the most cutting-edge treatments and the best research to give them the best chance of survival — this new hospital is part of that journey,” said Robert Stone, CEO of City of Hope.”

• Per Healthcare Dive,
  • “Cencora is acquiring a majority stake in OneOncology, a support platform for cancer care practices, for $5 billion as the drug distributor ramps up its specialty services offerings.
  • “Cencora already owned a stake in OneOncology, but has signed a definitive agreement to acquire most of the remaining shares from investment firm TPG and other holders for $3.6 billion, and to pay off $1.3 billion of OneOncology’s debt.
  • “OneOncology’s practices will retain a minority interest in the company, according to a release. Cencora expects deal to close by the second fiscal quarter next year.”

• Beckers Clinical Leadership points out,
  • “Concierge and direct primary care models are rapidly reshaping the U.S. primary care landscape. These membership-based practices, which charge monthly or annual fees for enhanced access and longer visits, have increased in recent years — often operating outside the traditional insurance system.
  • “A research article published in December in Health Affairs by researchers from Baltimore-based Johns Hopkins University, Portland-based Oregon Health & Science University and Boston-based Harvard Medical School found that such practices increased by more than 80% between 2018 and 2023, raising questions about equity, access and the future of the physician workforce.”

• Lockton issued its 2025 high cost claimant report.
  • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.
  • “Approximately 1% of an employer’s health plan members have annual claims higher than $100,000, but they account for 33% of total spend. And claims are growing more severe, complex, and unpredictable.”
  • “What’s changing is not only the magnitude of these claims, but also the instability. Only 21% of high-cost claimants (HCCs) persist year over year, increasing renewal uncertainty and complicating forecasting.”

• Per an Institute for Clinicial and Economic Review news release,
  • “The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of semaglutide (injectable Wegovy®, and a yet to be approved oral formulation) (Novo Nordisk) and tirzepatide (Zepbound®) (Eli Lilly and Company) for the treatment of obesity. The final report includes key policy recommendations to help ensure fair access.
  • “Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations “