Tuesday Report

From Washington, DC,

Capitol Hill News

  • Healthcare Dive tells us,
    • “A key congressional committee voted Tuesday to advance to a full Senate vote the nomination of prominent vaccine skeptic Robert F. Kennedy Jr. as the next U.S. health secretary.
    • “The 14-13 vote by the Senate Finance Committee was along party lines, with all 14 Republicans on the panel voting in favor of Kennedy. Among them was Sen. Bill Cassidy, R-La., a physician who said in a hearing last week that he was “struggling” with his vote because of Kennedy’s claims about vaccines.
    • “Cassidy said on social media platform X he voted yes after “very intense conversations” with Kennedy and the White House over the weekend.
    • “With the serious commitments I’ve received from the administration and the opportunity to make progress on the issues we agree on like healthy foods and a pro-American agenda, I will vote yes,” he said.”
  • The American Hospital Association News adds, “The Senate Feb. 4 confirmed Doug Collins as the new Department of Veterans Affairs secretary by a 77-23 vote.”
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) released the following statement after meeting with Dr. Mehmet Oz, President Trump’s nominee to be Centers for Medicare and Medicaid Services (CMS) Administrator:
    • “I had a constructive meeting with Dr. Oz, where we discussed his approach to health care policy and vision for CMS.  I value his advocacy for consumer choice and his commitment to expanding Americans’ access to affordable, high-quality health care.  I look forward to considering his nomination before the Finance Committee.”
  • Politico reports, “President Donald Trump’s nominee for attorney general, Pam Bondi, was confirmed by the Senate Tuesday evening, 54-46.

OPM News

  • Govexec informs us,
    • “With just two days remaining before the deadline for federal workers to accept or reject the Trump administration’s so-called deferred resignation program, agencies are again defending its legality and increasingly coaxing feds to take the deal.
    • “Federal workers have until Thursday to respond to one of a series of emails offering what Trump officials are calling “buyouts,” in which a federal worker is paid their current salary and benefits until Sept. 30 though will have effectively quit by the end of February. Administration officials say employees who accept the deal will be placed on paid administrative leave—in an apparent effort to circumvent the $25,000 cap on Voluntary Separation Incentive Payments—while the Office of Personnel Management has already begun granting agencies Voluntary Early Retirement Authority for eligible federal workers.
    • “But according to Axios, only 20,000 feds have thus far accepted the deal, which has been widely panned by Democrats and federal employee groups as illegal and unenforceable. That accounts for less than 1% of the 2.3 million federal workers, and well below the White House’s reported target of 10%.” * * *
    • “OPM on Tuesday issued new guidance seeking to defend the offer’s legality, insisting that the agreement resigning federal workers will sign legally binds agencies into maintaining their pay and benefits until September.”
  • Federal News Network points out,
    • “Agencies have until Noon on Wednesday to send the Office of Personnel Management a list of employees on probation and say whether or not they want to keep them.
    • “Federal sources confirm OPM asked agencies to submit their lists and gave them a 200-character limit to explain why the employee should stay in government.” * * *
    • “Data on how many employees are under a probationary period is not readily available. The latest data from Fedscope is from March 2024 and shows more than 220,000 federal employees were within their one-year probationary period. That number may indicate generally how many newly hired employees are in the federal workforce at any given time.”

Food and Drug Administration News

  • The Hill reports
    • “The Food and Drug Administration has upgraded its classification of a broccoli recall initially reported in late December, labeling it as “Class I” — the agency’s most serious recall category.
    • “Braga Fresh, of Salinas, California, had initially issued an “advisory” for a specific lot of Marketside Broccoli Florets in late December, after Health and Human Services workers discovered Listeria monocytogenes in “multiple samples” from a Texas Walmart.
    • “The broccoli had been distributed to Walmart stores in 20 states: Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.
    • “No illnesses had been reported at the time of the initial advisory. Consumers were advised to throw away the potentially affected product and contact Braga Fresh with any other concerns.
    • “In late January, however, the FDA upgraded the recall to a Class I, the FDA’s website shows.
    • “Class I, the FDA says, involve “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
  • Per Fierce Pharma
    • “Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.
    • “The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.
    • “Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earnedendorsement from the FDA to put it back on the market. 
    • ‘Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.”
  • STAT News reports,
    • “Amgen said Tuesday that the Food and Drug Administration has ordered a hold on a study of the company’s early-stage obesity candidate, another potential setback in the company’s efforts to join the booming weight loss drug market.
    • “Amgen has so far said little about the drug, dubbed AMG 513, and has not described the drug’s mechanism. On a call with analysts, Amgen executives did not explain why AMG 513 is on a clinical hold, other than to say “it’s not related to the drug” and that discussions are underway to reopen the study.” 

Miscellany

  • The Social Security Administration has created a set of online FAQs about the Social Security Fairness Act.
  • The Groom Law Group discusses the CMS simplified prescription drug creditable coverage methodology proposed on January 10. “Comments on the Draft CY 2026 Part D Redesign Program Instructions are due to CMS no later than February 10, 2025. and must be submitted to PartDRedesignPI@cms.hhs.gov with the subject line “Draft CY 2026 Part D Redesign Program Instructions.”

From the public health and medical research front,

  • Healio lets us know,
    • “World Cancer Day [is] Feb. 4.
    • “Union for International Cancer Control (UICC) created World Cancer Day in 2000 to educate the public about the importance of early detection and treatment, encourage elected representatives to commit ample resources to reduce cancer mortality, and increase awareness that lifestyle behaviors have a considerable effect on cancer risk.
    • “This year’s World Cancer Day is the first of a 3-year campaign with the theme “United by Unique.” The campaign is designed to promote the need for “a fundamental shift in cancer care and health systems” around the world toward a people-centered approach, according to a UICC press release.
  • and
    • “SGLT2 inhibitors confer greater risk reductions for major adverse cardiovascular events in older adults with type 2 diabetes compared with younger adults, according to findings from a systematic review and meta-analysis published in JAMA.” * * *\
    • “Age should not be a barrier to treatment with SGLT2 inhibitors in patients who are likely to benefit from reduced CV risk,” Peter Hanlon, PhD, clinical senior research fellow in the School of Health and Wellbeing at University of Glasgow in the U.K., told Healio. “It also suggests that for these treatments that have a proven CV benefit, change in blood glucose may be a poor indicator of the protective effect on CV outcomes.”
  • The Wall Street Journal discusses “The Right White Noise for a Good Night’s Sleep. Plus, some of our favorite products for blocking annoying sounds.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “On Tuesday, Centene touted healthy membership growth in Affordable Care Act plans, while arguing that Medicaid and Medicare — businesses that proved rocky last year — will stabilize in 2025.
    • “Already the largest marketplace carrier, Centene now has upwards of 5 million ACA members paying premiums, executives told investors during a call to discuss its fourth-quarter results. That’s compared to 4.8 million members at the end of 2024.
    • “Growth in ACA members was a major contributor to Centene’s $3.3 million in profit last year, according to the company. However, Centene expects enrollment to peak in the first quarter before sliding back down over the year, in part from efforts to improve program integrity, CEO Sarah London said.”
  • Per Fierce Pharma,
    • “The continued decline of Merck & Co.’s HPV vaccine Gardasil in China has come to a head as the New Jersey drug giant is halting shipments to the world’s second-most populous country.
    • “Thanks to ongoing market challenges, Merck is temporarily cutting off Gardasil deliveries to China from February through at least the middle of 2025. The move should help the drugmaker clear out excess doses of the vaccine cluttering its inventory, Merck said (PDF) in an earnings presentation Tuesday.
    • “Over the last three months of 2024, Gardasil generated $1.6 billion in sales globally, signaling an 18% decline compared to the same period in 2023. For the full year, during which Merck generated total revenues of $64.2 billion, Gardasil sales dropped 3% to $8.6 billion.”
  • Per Healthcare Dive,
    • “HCA Healthcare completed its $110 million purchase of Manchester, New Hampshire-based Catholic Medical Center on Feb. 1, a spokesperson confirmed to Healthcare Dive. The deal is the latest in a growing trend of hospital acquisitions motivated by financial distress.
    • “HCA received regulatory approval to purchase CMC in January, after the New Hampshire attorney general’s office determined CMC was on the brink of bankruptcy and could soon close its 330-bed acute care facility without a buyer.
    • “Regulators imposed significant conditions on the sale and will monitor HCA for compliance over 10 years. For example, HCA will be required to invest $200 million to expand healthcare capacity in New Hampshire and preserve critical service lines for the duration of the monitoring period, including pregnancy care.”
  • and
    • Prospect Medical Holdings said Monday it has a deal to sell its two hospitals in Rhode Island — collectively called CharterCARE Health Partners — for approximately $160 million to the Centurion Foundation, a nonprofit healthcare operator based in Georgia. 
    • The deal precedes Prospect’s January Chapter 11 bankruptcy filing. Prospect and Centurion signed a definitive agreement in 2022, and Rhode Island regulators approved the sale last year. However, the attorney general’s office placed 40 closing conditions on the sale. In first day bankruptcy motions, Prospect said the terms were too onerous for the cash-strapped system to meet.
    • In a statement to Healthcare Dive, a spokesperson for the Rhode Island attorney general’s office was steadfast, saying the parties “must comply” with the regulators’ terms as laid out last year. “We are reviewing their filing carefully to determine whether their proposed sale does so,” the spokesperson said.

Leave a Reply

Your email address will not be published. Required fields are marked *