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From Washington, DC
The House of Representatives and the Senate are in session on Capitol Hill for Committee business and floor voting this week.
On Saturday, the House Appropriations Committee unveiled “The Full-Year Continuing Appropriations and Extensions Act, 2025.”
The Wall Street Journal adds,
“House lawmakers are expected to vote on the proposal, termed a continuing resolution or CR, as soon as Tuesday, with a majority needed to pass it. But even if House Republicans manage to stay united and pass the proposal over Democratic opposition, it will need at least 60 votes in the Senate, which has only 53 Republican lawmakers.
“Funding for federal agencies runs out on Friday night. With no new legislation, many federal employees would be furloughed, while others would continue to report to work with no pay.”
The Senate will be voting to confirm the President’s nominee for Secretary of Labor Lori Chavez-DeRemer Monday afternoon.
Committee meetings of note:
Committee: House Oversight and Government Reform Subcommittee: House Oversight and Government Reform Subcommittee on Government Operations Subject: “Shifting Gears: Moving from Recovery to Prevention of Improper Payments and Fraud” Date: 03/11/2025 (10:00 AM Local Time)(Add to My Calendar) Location: 2247 Rayburn House Office Building, Washington, D.C.
Committee: Senate Health, Education, Labor, and Pensions. Subject: Business meeting to consider the nominations of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health, and Martin Makary, of Virginia, to be Commissioner of Food and Drugs, both of the Department of Health and Human Services, and other pending calendar business Related Items: PN12-2, PN12-28 Date: 03/13/2025 (9:30 AM Local Time) (Add to My Calendar) Location: 562 Dirksen Senate Office Building, Washington, D.C.
Committee Senate Finance Committee Subject: Hearing to consider the nomination of Dr. Mehmet Oz to be CMS Administrator Witness: Dr. Mehmet Oz Date: Friday, March 14, 2025, 10:00 AM Local Time) Location: 215 Dirksen Senate Office Building, Washington, DC
The AP explains “How a health savings account fits into your retirement strategy.”
From the public health front,
The Wall Street Journal explores how “One Couple in Their 90s Confronts a Stark Reality: Aging at Different Speeds; Lifelong partners grapple with how and whether to stay together when one can’t care for the other.”
The New York Times points out six sources of protein that are not meat and answers questions about fentanyl.
Researchers from the University of Texas Health Science Center at San Antonio have developed a drug that more than doubled median survival time and progression-free time for patients with glioblastoma during a clinical trial.
Patients who received the drug Rhenium Obisbemeda, or 186RNL, also experienced no dose-limiting toxic effects, according to a March 7 news release from UT Health San Antonio.
Glioblastoma is the most common form of brain tumor, with more than 90% of patients experiencing recurrence. If standard treatment fails, the median survival time is about eight months, the release said. \
“Glioblastoma has needed durable treatments that can directly target the tumor while sparing healthy tissue,” Andrew Brenner, MD, PhD, professor and chair of neuro-oncology research with Mays Cancer Center at UT Health San Antonio, said in the release. “This trial provides hope, with a second phase under way and planned for completion by the end of this year.”
“Higher volumes, more favorable reimbursement rates and more efficient labor spending helped Providence cut its 2024 operating losses nearly in half.
“On Thursday the nonprofit system reported a $644 million operating loss (-2.1% operating loss) across 2024, a stark improvement over the $1.17 billion operating loss (-4.1% operating margin) of the year prior. The 2024 tally includes $183 million in reconstruction costs “related to asset rationalization, employee reductions and other items,” according to its filing.
“Operating revenues across the system grew 7% year over year to $30.7 billion (5% when excluding a $426 million net gain in the first quarter), with management noting in its filing that the growth was spread across all of its operating categories.”
“Earlier this week, Eli Lilly partnered up with telehealth providers LifeMD and Teladoc Health to offer its lower cost, single-vial Zepbound (tirzepatide) to patients in the virtual care companies’ full-service weight loss management programs.
“The companies are directly contracting with Eli Lilly’s self-pay pharmacy, GiftHealth. The move could be a boon for telehealth weight loss programs, which have proved lucrative for virtual primary care companies. Many of the chronic condition management programs, including for weight loss, also offer remote monitoring, access to dietitians and health coaches, as well as the ability to be prescribed medication for weight loss, including older medications.
“The announcement follows Eli Lilly’s partnership with telehealth platform Ro three months ago. The pharmaceutical company launched its own direct-to-consumer telehealth offering for weight loss in January 2024. Now, it seems to be creating a marketplace of access.”
Beckers Payer Issues ranks Medicare insurers by the quality of their mobile applications.
“Lawmakers who support tough rules on pharmacy benefit managers reaffirmed their ambitions to reanimate legislation that nearly passed Congress in December.
“The House Energy and Commerce Committee’s Health Subcommittee relaunched the push at a hearing Tuesday that featured declarations from majority Republicans and minority Democrats that they will tackle high pharmaceutical prices and limited competition in the PBM market through bills that have lingered for more than a year without final action.
“I can tell you it is a priority of mine to ensure these commonsense and bipartisan policies become law,” Energy and Commerce Committee Chair Brett Guthrie (R-Ky.) said at the hearing.”
Per a Senate news release,
“In a Wall Street Journalletter to the editor, Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.) welcomed Health and Human Services Secretary Robert F. Kennedy Jr.’s support for enhanced transparency regarding direct-to-consumer (DTC) prescription-drug advertisements. Grassley and Durbin are leading bipartisan legislation to require price disclosures in DTC commercials.”
“Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Act in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines.
“The legislation, known as the Ensuring Pathways to Innovative Cures Act, would allow Medicare to begin negotiating with pharmaceutical companies over the prices of small molecule medicines 13 years after they reach the market. Currently, negotiations begin after nine years and the legislation — which was re-introduced by Rep. Greg Murphy (R-N.C.) — would shift the timetable so that it is the same as for large molecule medicines, also known as biologics.
“By making this change, the legislation would remove what the pharmaceutical industry and its investors claim is a disincentive for pursuing small molecule drugs, since these medicines would have less time on the market before Medicare would be able to negotiate set prices. This process means there will be small returns on investments for small molecule drugs, according to those who support the bill.”
The American Hospital Association News (AHA) tells us,
“Both chambers of Congress have reintroduced AHA-supported legislation, the Conrad State 30 and Physician Access Reauthorization Act (S. 709]/H.R. 1585), to reauthorize and expand the program that allows foreign-born medical graduates to practice medicine in rural and underserved areas. The bipartisan legislation extends the program for three years and would increase current state allocations from 30 to 35 physicians per year. It would also provide flexibility to expand the number of waivers in states where demand exceeds that limit.”
“The White House yesterday issued an executive order that directs the Departments of Health and Human Services, Labor, and Treasury to improve upon and increase enforcement of the hospital and insurer price transparency requirements in the Hospital Price Transparency and Transparency in Coverage regulations. Specifically, the White House instructs the departments to “rapidly implement and enforce” the regulations, including by taking actions in the next 90 days to increase enforcement and standardization and ensure that “actual prices,” rather than estimates are disclosed.”
Beckers Payer Issues offers six notes for payers on this Executive Order.
“The Trump administration has given federal agencies until March 13 to deliver their plans to dramatically slash their workforces through layoffs as the Trump administration moves to the second phase of its initiative to cut federal employees.
“The plans will focus on the “maximum elimination” of functions not required by law, Office of Management and Budget director and Office of Personnel Management acting Director Charles Ezell said in new guidance on Wednesday, and include a resulting “significant reduction” in employees. As a starting point for the cuts, Vought and Ezell said, agencies should focus on employees whose jobs are not required in statute and who face furloughs in government shutdowns—typically around one-third of the federal workforce, or 700,000 employees.
“Pursuant to the president’s direction, agencies should focus on the maximum elimination of functions that are not statutorily mandated while driving the highest-quality, most efficient delivery of their statutorily required functions,” Vought and Ezell said.”
“The Trump administration is giving federal agenciesuntil mid-April to suggest relocations of bureaus and offices out of the D.C. region, a move that would have widespread impacts on the local economy.
“In a guidance issued Wednesday to the heads of all executive departments and agencies, the directors of the Office of Management and Budget and the Office of Personnel Management laid out steps for compliance with President Donald Trump’s order to eliminate “waste, bloat and insularity” in the government. Part of that is a directive to submit “any proposed relocations of agency bureaus and offices from Washington, D.C. and the National Capital Region to less-costly parts of the country” by April 14.” * * *
“Also on Wednesday, Trump issued an executive order giving agencies seven days to submit an inventory of their real property and 30 days to identify all leases that can be terminated. Within 60 days, the order stated, the General Services Administration — the government’s real estate arm — must come up with a plan to dispose all property deemed “no longer needed.”
“US health officials are reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna Inc., people familiar with the matter said.
“The review is part of a government push to examine spending on messenger RNA-based vaccines, the technology that powered Moderna’s Covid vaccine. The bird flu shot contract was awarded to Moderna in the Biden administration’s final days, sending the company’s stock up 13% in the two days following the Jan. 17 announcement.”
“Just over 34.4 million people were enrolled in Medicare Advantage (MA) plans as of Feb. 1, representing fairly slim growth across the program’s annual enrollment period.
“Enrollment grew by 3.8% from February 2024 to February 2025, according to anticipated data released this week from the Centers for Medicare & Medicaid Services. This would make for the lowest growth rate in more than a decade, according to researchers at KFF.
“The KFF analysts said enrollment in MA has more than doubled since 2010.”
“While lobbyists are supplicating President Donald Trump and the Republican-led Congress to continue their leadership on telehealth and extend expiring flexibilities—which Trump began during the COVID-19 pandemic—they no longer are asking for a concrete timeline.
“Three hundred and fifty organizations signed a letter to congressional leadership Monday urging lawmakers to extend expiring Medicare telehealth flexibilities and to restore telehealth access lost by commercially insured patients in December.
“The organizations told Congress that they prefer to make the telehealth flexibilities permanent. However, in a messaging shift, the groups said they “recognize this could be a multi-year process” and asked Congress to consider a “long-term” extension.”
“The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.
“The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.” * * *
“In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
“Physicians have long complained that, as a result, clozapine is grossly underutilized.
“Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.
“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”
From the public health and medical research front,
“A child who tested positive for measles died in West Texas, the state health department said, marking the first death in an outbreak that has sickened nearly 140 people.
“The Texas Department of State Health Services said a school-age child died after being hospitalized in Lubbock. The child wasn’t vaccinated, the state health department said.
“The child’s death marked the first measles-related death in the U.S. since 2015.” * * *
“The reality of this outbreak is pushing more people to get vaccinated, said Katherine Wells, director of public health in Lubbock. The public-health department has administered around 100 more measles vaccines over the past week or two than they do normally. More than half of those went to children receiving the vaccine for the first time. School nurses also checked students’ vaccine records and alerted parents if their sons or daughters hadn’t received their second dose yet, Wells said.
“The goal right now is to find pockets of unvaccinated people who have not yet been exposed and just get our vaccination rates up as high as possible,” Wells said. “That’s what’s going to slow this down.”
“This season’s influenza vaccine may have been a poor match to a strain of the flu virus that caused many infections this winter, early data released by the Centers for Disease Control and Prevention suggests.
The National Cancer Institute tells us whether “AI Help Predict Which Cancer Patients Should Be Treated with Immunotherapy?” and offers Cancer Information Highlights about “Metastatic Prostate Cancer | Prenatal Blood Test | Nivolumab via Injection.”
“Frequent exercise can help colon cancer survivors live longer, perhaps even outlasting average folks, a new study suggests.
“Colon cancer patients who were very physically active had three-year survival rates that were slightly higher than the general population, researchers report in the journal Cancer.
“This new information can help patients with colon cancer understand how factors that they can control — their physical activity levels — can have a meaningful impact on their long-term prognosis,” lead researcher Justin Brown, director of the Cancer Metabolism Program with the Pennington Biomedical Research Center at Louisiana State University, said in a news release.”
“Pregnant women with low vitamin D levels during the first trimester were four times more likely to give birth prematurely compared with women with adequate vitamin D levels, researchers wrote in TheAmerican Journal of Clinical Nutrition.
“Testing for vitamin D status is not currently part of standard prenatal care in the U.S.,” Alison D. Gernand, PhD, MPH, RD,associate professor of nutritional sciences at Pennsylvania State University, told Healio. “Clinical care providers should consider talking to pregnant patients about vitamin D during the first prenatal visit — asking whether they have vitamin D-rich foods in their diet and how much vitamin D is in the supplement they are taking.”
“Among populations with low adherence to colorectal cancer screening, annual fecal immunochemical testing was the cheapest and most effective noninvasive screening method, according to a study published in JAMA Network Open“
“AstraZeneca said Wednesday that its experimental drug camizestrant delayed tumor progression in a Phase 3 testing its use as a first-line treatment in people with a certain type of breast cancer. The drug, an oral, hormone receptor protein-degrading therapy known as a SERD, was tested alongside an approved CDK4/6 inhibitor in people whose HR-positive, HER2-negative tumors have an “emergent” ESR1 mutation. People in the study were receiving standard hormone therapy and a CDK4/6 drug and then either continued, or swapped out the hormone treatment for camizestrant, once a tumor scan showed signs of an ESR1 mutation. The result was a “highly statistically significant and clinically meaningful improvement” in progression-free survival for camizestrant recipients, AstraZeneca said. Menarini Group’s similar drug Orserdu is available in the second line setting, while others from Arvinas, Eli Lilly and Roche are in advanced testing.”
“Drugmaker Eli Lilly plans to build four new manufacturing plants in the U.S., a $27 billion investment that the company expects will create 3,000 high-skilled jobs and employ 10,000 construction workers.
“Three of the new sites would produce active pharmaceutical ingredients for its drugs, and the fourth would produce sterile injectable medicines such as diabetes drug Mounjaro, Lilly said Wednesday. The company hasn’t picked the locations yet. It expects the plants to be making medicines within five years.
“It comes as Lilly and other pharmaceutical companies seek warm relations with the new administration and press it to pursue industry objectives, including the extension of corporate tax cuts enacted during the first Trump administration.
“We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Lilly Chief Executive David Ricks said in an interview.”
“Mobile medical units will deliver hospital-at-home care to patients in rural communities as part of a five-year pilot program aimed at expanding healthcare access in underserved areas.
“The Advanced Research Projects Agency for Health recently awarded an undisclosed amount of funding to Boston’s Mass General Brigham, University of Utah’s Huntsman Cancer Institute and Kentwood, Michigan-based Homeward Health to develop programs that will extend hospital-level care to patients in remote communities using mobile platforms.
“Health systems have used hospital-at-home as a way to ease overcrowding and free up beds. More than 380 hospitals have Medicare waivers allowing them to provide acute care to patients where they live at the same reimbursement rate as an inpatient stay. While the waiver is set to expire at the end of March, there has been bipartisan support to continue it and hospitals continue to launch in-home acute care programs.
“But the concept has not taken off in rural America, in part because the CMS waiver requires patients to live within 25 miles of a participating hospital. Staffing can also be a challenge, as well as patient buy-in.”
“Teladoc posted a net loss of just over $1 billion in 2024 related to ongoing struggles at its direct-to-consumer BetterHelp business that are expected to continue this year.
“The annual net loss of $1 billion, or $5.87 per share, reported Wednesday, compared with a 2023 loss of $220 million, or $1.34 per share. The company took a non-cash goodwill impairment charge of $790 million attributed to BetterHelp. Revenue tied to BetterHelp, which Teladoc acquired in June 2015 for $4 million, decreased 8% in 2024. Overall revenue declined 1%.
“Compared with a year ago, fourth-quarter revenue decreased 3% and its net loss was 68% worse.
“The outlook for this year isn’t encouraging. The company said it expects BetterHelp revenue to decline nearly 10%. Still, during an earnings call, CEO Chuck Divita was bullish on the direct-to-consumer segment and said Teladoc will pursue strategies to turn the company around.”
“Sixty-five percent of healthcare executives are prioritizing growth strategies to increase revenue, according to the Deloitte Center for Health Solutions. And health system leaders expect consumers to play a major role in their organizations’ organic growth.
“The survey from Deloitte underscored a shift from merger and acquisition activity as a means of growing revenue to consumer attraction and retention. However, to attract new consumers and drive organic growth, over half of health system executives (and about half of health plan leaders) said they need to improve consumer engagement, trust and the overall patient experience.”
“The Department of Health and Human Services (HHS) is firing up to 5,200 probationary employees today, as part of an unprecedented cutting of jobs across the federal government.
“Of the impacted workers, 1,300 are employed by the Centers for Disease Control and Prevention (CDC) while a sizeable portion work for the National Institutes of Health (NIH). Employees were given four weeks paid administrative leave and notified on the morning of Feb. 14, as first reported by the Associated Press.” * * *
“The Department of Veterans Affairs announced layoffs Thursday affecting more than 1,000 federal workers, in a move the Trump administration said would save $98 million per year.”
The Trump administration’s effort to slash the federal workforce is pushing employees into a challenging job market, where their age and lack of corporate experience can hold them back.
Federal workers are also facing an environment where hiring for white-collar jobs has slowed.
Despite the availability of state and local government jobs, many of these positions take place outside offices and aren’t a good match for federal workers’ experience.
“President Trump Feb. 13 signed a presidential memorandum ordering the development of a comprehensive plan for “restoring fairness in U.S. trade relationships and countering non-reciprocal trading arrangements.”
“The announcement directs the U.S. Trade Representative and the Secretary of Commerce, in consultation with the secretaries of a number of U.S. agencies, to develop plans for reciprocal tariffs on every country that taxes U.S. imports and submit a report to the president. In addition, within 180 days of the memo, the director of the Office of Management and Budget will assess all fiscal impacts on the federal government and the impacts of any information collection requests on the public and deliver an assessment in writing to the president.
From the public health and medical research front,
The Centers for Disease Control and Prevention announced today,
COVID-19
“COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is stable. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
“There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
“CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.”
Influenza
“Seasonal influenza activity is higher than it has been all season. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC.”
RSV
“RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.”
Vaccination
“Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
“How long will vaccine protection last? A simple blood test may have the answer. Researchers at Stanford School of Medicine, Stanford, California, have identified a molecular signature in the blood that appears days after vaccination and predicts the durability of the immune response. Published in Nature Immunology in January, this discovery could transform vaccine development, testing, and personalization of vaccines. The study also offers insights into why some vaccines provide lifelong immunity while others lose effectiveness within months.”
“The percentage of U.S. adults with obesity did not significantly rise from 2013 to 2023, though a small uptick in the rate of obesity was seen for children and adolescents, according to data published in JAMA.
“From 2013 to August 2023, there were small increases in obesity in children and adolescents aged 2 to 19 years, driven by increases among males and children aged 2 to 5 years,” Samuel D. Emmerich, DVM, an epidemiologist at the CDC National Center for Health Statistics, told Healio. “In adults aged 20 years and older, severe obesity increased slightly, driven by increases among women and middle-aged adults. There were no significant changes in any other subgroups, in high weight-for-length or in high waist circumference.”
“New research is shedding light on a heightened risk of colorectal cancer (CRC) in patients with both nonadvanced and advanced adenomas detected during colonoscopy, highlighting the importance of surveillance colonoscopy in this population and the need for more frequent screening among those with advanced adenomas.
“Leveraging data from the Minnesota Colon Cancer Control Study, the present analysis found individuals with adenomas at colonoscopy, regardless of whether or not they were advanced, were at a greater risk of developing CRC than those with no adenomas. Additionally, findings showed participants with advanced adenomas were at increased risk of both CRC mortality and all-cause mortality.
“Studies have reported the association of advanced adenomas with increased risk of CRC and CRC-related death over the following 5 to 15 years compared with having no advanced adenomas. The association of nonadvanced adenomas with CRC incidence and mortality after colonoscopy is less clear,” Aasma Shaukat, MD, MPH, a gastroenterologist and Robert M. and Mary H. Glickman Professor of Medicine at New York University Grossman School of Medicine, and colleagues wrote. “However, to our knowledge, no studies have evaluated the association of adenomas and advanced adenomas with all-cause mortality.”
“You may be less likely to develop an especially lethal form of colon cancer if you’re a longtime consumer of yogurt, new research finds.
“Folks who ate two or more servings of yogurt per week for years had 20% lower odds for an aggressive type of tumor typically found on the right side of the colon, researchers reported Feb. 12 in the journal Gut Microbes.
“The tumors’ tissues also tested positive for a bacterium commonly found in yogurt, called Bifidobacterium.
“It has long been believed that yogurt and other fermented milk products are beneficial for gastrointestinal health,” co-senior author Dr. Tomotaka Ugai, a pathologist at Mass General Brigham in Boston, noted. “Our new findings suggest that this protective effect may be specific for Bifidobacterium-positive tumors.”
“Johnson & Johnson’s halt of U.S. sales of a new heart-rhythm device due to safety concerns is hobbling a major strategic push by the company into one of the industry’s fastest-growing markets.
“The healthcare company paused use of the device, known as Varipulse, last month after receiving reports of neurovascular events in several patients. The company didn’t explain what the events were, but several strokes have been reported to a federal device-safety database, and doctors’ concerns are centered on strokes.
“J&J has been racing to catch up to competitors in the fast-growing market for medical devices treating irregular heart rhythms, and to revive the company’s medical-device business generally.
“Rivals Boston Scientific and Medtronic have dominated the market for so-called pulsed-field ablation devices, which research firm Clarivate estimates will reach about $12 billion by 2032, from $1.6 billion last year.
“More than 10 million Americans have the heart-rhythm disorder that the devices treat.
“This is a huge hit for J&J,” said Dr. John Mandrola, an electrophysiologist at Baptist Health in Louisville, Ky., who treats patients with heart-rhythm problems. “The market’s so big, and this just sets them back.”
Beckers Payer Issues lists major health insurers by 2024 medical loss ratios.
Kaufmann Hall takes a look at “Navigating Health Systems Through a Decade of Change” via a conversation with Rich Liekweg, CEO of BJC Health System in Missouri, and Nick Barto, president of BJC Health System.
The American Hospital Association (AHA) News tells us,
House Republicans Jan. 12 released a budget resolution for fiscal year 2025 focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution, which acts as an outline for the reconciliation process, calls for increasing the debt ceiling by $4 trillion and allows for $4.5 trillion in spending for tax cuts. It also would allocate $200 billion for border and defense spending. The resolution instructs seven committees to come up with no less than $1.502 trillion in mandatory cuts over ten years.
Notably, for health care, the bill instructs the House Energy and Commerce Committee to cut mandatory spending by no less than $880 billion. The committee has primary jurisdiction over a number of health care programs, including Medicaid, and some proposals have been circulating that would enact significant cuts to Medicaid. The House is expected to mark up its budget resolution tomorrow.
“Senate Republicans easily pushed their budget resolution out of committee on Wednesday — the first step toward being able to enact President Donald Trump’s massive domestic policy agenda.
“The Senate Budget Committee voted 11-10, along party lines, to approve the fiscal framework meant to tee up a package of energy, border security and defense policy through the partisan budget reconciliation process. Across the Capitol, House GOP leaders struggled at the same time to rally their own around a far more expansive plan that would pave the way for legislation that would bundle those same policies alongside trillions of dollars in tax cuts.”
The Senate Invoked, 53-47: Motion to invoke cloture on Executive Calendar #17 Robert F. Kennedy, Jr. to be Secretary of HHS. The Senate is expected to confirm Mr. Kennedy’s nomination as HHS Secretary Thursday morning.
Senators Chuck Grassley (R IA) and Maria Cantwell (D WA) have re-introduced the PBM reform bills that nearly passed Congress last December.
Fierce Healthcare lays out the “top policy issues for hospitals, payers, docs and tech” on Capitol Hill this year.
White House news
Here is a link to the President’s February 11 executive order captioned “IMPLEMENTING THE PRESIDENT’S “DEPARTMENT OF GOVERNMENT EFFICIENCY” WORKFORCE OPTIMIZATION INITIATIVE,” which was mentioned in Tuesday’s report.
The American Society of Pension Professionals and Actuaries lets us know,
“Daniel Aronowitz has been officially nominated by the White House to become next Assistant Secretary of Labor for the Employee Benefits Security Administration (EBSA). He is the President of Euclid Fiduciary (now Encore Fiduciary), a fiduciary liability insurance underwriting company for employee benefit plans.
“His experience in the professional liability industry includes expertise as a coverage lawyer and underwriter.”
The AHA News informs us, “Tom Engels is the new administrator for the Health Resources and Services Administration, according to its website. Engels previously held the same position in the first Trump administration from 2019 to 2021.”
Federal News Network updates us on federal agency efforts to bring their workforces back to office.
“The Trump administration is free to continue implementing its controversial deferred resignation program after a federal court in Massachusetts dissolved a restraining order that had delayed the program’s deadline by several days.
“In a written opinion Wednesday afternoon, Judge George O’Toole said he had determined that the three federal unions that had challenged the program lacked the standing they’d need in order to meet the legal standard for a temporary restraining order.” * * *
“Wednesday’s ruling does not completely end the legal challenge — it only affects the unions’ requests for a temporary pause in the deferred resignation program while their claims work their way through the litigation process. However, in denying a temporary restraining order and preliminary injunction, O’Toole said he had determined the unions were unlikely to succeed on the merits of their case.
“OPM is pleased the court has rejected a desperate effort to strike down the deferred resignation program. As of 7 p.m. tonight, the program is now closed,” said McLaurine Pinover, a spokeswoman for the office. “There is no longer any doubt: the deferred resignation program was both legal and a valuable option for federal employees. This program was carefully designed, thoroughly vetted, and provides generous benefits so federal workers can plan for their futures.”
In fact, the Fork in the Road program closed at 7:20 pm ET Wednesday night per its website.
“More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
“The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
“Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.”
From the public health and medical research front,
“For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25, according to weekly figures published by the Centers for Disease Control and Prevention.
“For the week ending on Jan. 25, nearly 1.7% of all deaths nationwide were attributed to the flu, compared to roughly 1.5% being the result of COVID-19, according to CDC data. Rates of influenza hospitalizations are more than three times higher than COVID-19 hospitalizations amid this season’s record wave of flu infections.”
“The U.S. confirmed at least a dozen deaths from whooping cough last year, according to preliminary figures released this week by the Centers for Disease Control and Prevention. That marks the most fatalities from the bacterial infection since a 2017 surge of the illness, which is also known as pertussis.
“Over the last month, pertussis infections have been rising again. While cases reported to the CDC by health departments dipped over the winter holidays, weekly infections have accelerated for a month straight since then.”
“A worsening measles outbreak has taken root in Texas, sickening two dozen and hospitalizing nine on the western edge of the state, where childhood vaccination rates have dwindled in recent years.
“As of Tuesday, 22 children and two adults had been infected, all of whom were unvaccinated, local health officials said. * * *
“The Texas outbreak has so far been limited to residents of Gaines County, which borders New Mexico and has roughly 20,000 residents. Last year 82 percent of kindergarten students received the measles, mumps and rubella vaccine, according to state data. That figure is roughly 10 percentage points lower than the average vaccination rate in Texas public schools and far below the federal target of 95 percent for measles vaccination.”
Nature points out that “Dozens of new obesity drugs are coming; these are the ones to watch. Next-generation obesity drugs will work differently from Ozempic and Wegovy — aiming to deliver greater weight loss with fewer side effects.”
BioPharma Dive, on the other hand, lets us know “A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit.”
“More than five years ago, Apple launched three medical studies to test how well its Apple Watch can track a person’s mobility and cardiovascular health, changes in hearing and women’s health and fertility.
“The tech company is now broadening its health research ambitions to use its devices, including iPhones, Apple Watch and AirPods along with third-party devices, for a longitudinal, virtual study to monitor changes in participants’ health, spanning a wide range of health and disease areas.
“Apple wants to tap into the devices and apps that individuals use every day to evaluate the connections between physical and mental health as well as social determinants, such as whether someone lives alone or with family, and how all these aspects of health factor into a person’s overall well-being.”
“In the insurance unit, CVS spent 94.8% of premium revenue on medical care in the quarter, less than analysts expected. Investors prefer a lower number. However, CVS said in a separate filing that high use of medical services will continue to pressure the business.
“The company pointed in particular to high costs in its business that manages care for patients on Medicaid, the US health program for the poor. States have been cutting Medicaid rolls since the pandemic, often culling healthier patients in the program while sicker patients remain.”
“CVS Health CEO David Joyner went on the defense of the pharmacy benefit management industry on the company’s Q4 earnings call Wednesday morning.” * * *
“One of the most powerful forces helping to offset rising healthcare costs is PBMs like Caremark,” Joyner said. “These entities remain the only part of the drug supply chain and entirely focused on lowering costs, but have erroneously been subject to deceptive rhetoric and misinformation.”
“Joyner noted that branded pharmaceutical manufacturers “added $21 billion of annual gross drug spend through their price actions” in January. Drugs where PBMs lack tools to negotiate prices have seen prices rise more than twice as fast as other products, he said.
“In addition, Joyner said that “multiple well-known economists” have projected that PBMs create $100 billion in net value each year for the healthcare system.”
The Council for Affordable Quality Healthcare Feb. 11 released a report highlighting how the health care industry can save $20 billion by transitioning from manual to electronic workflows.
In addition, it found that the industry could save $515 million annually on electronic prior authorizations and save providers and staff 14 minutes per transaction.
“UnitedHealth Group and Amedisys outlined plans to divest a significant number of home health and hospice locations as they seek to close their $3.3 billion merger.
“In a court filing issued late last week, UHG said it intends to pursue a divestiture plan that would sell off “at minimum” 128 combined home health and hospice facilities. The company said in the filing that once the divestitures are completed it will operate only 10% of home health services in the U.S. and 4% of hospice services.
“UnitedHealth argued that leaves plenty of competition in this space, as it will still be up against 11,000 home health agencies and more than 5,000 hospice agencies across the U.S.
‘The Department of Justice sued to block the deal in mid-November, arguing that it would hamper competition across multiple home health markets.”
“Question How have the proportion and absolute number of psychiatrists providing professional services to traditional Medicare enrollees changed as the field has grown?
“Findings In this cross-sectional study using data from 2014 to 2022, the nationwide proportion of psychiatrists billing Medicare Part B declined from 44% in 2014 to 33% in 2022. The number of psychiatrists billing Medicare Part B declined by 3772 during a time when the total number of active psychiatrists increased by 6076.
“Meaning These findings suggest that during a time of psychiatrist workforce growth, the proportion and number of psychiatrists accepting Medicare Part B decreased, further suggesting potential decreases in access to psychiatrist-led care for older adults and individuals with disabilities.”
“House Republicans wrapped up a more than four-hour meeting at the White House saying that they had closed gaps in their own internal disagreements over extending expiring tax cuts and cutting spending, and they indicated that they were on track to hold a key committee vote next week.
“We had a very productive meeting at the White House,” House Majority Leader Steve Scalise (R., La.) told reporters after lawmakers streamed into the Capitol. “We are narrowing down the areas of differences.”
“House Republicans from different factions of the party assembled at the White House, each hoping to get Trump’s support for their proposals and resolve disputes that have slowed the party’s progress on taxes, spending and immigration.”
The Senate press gallery tells us Thursday evening, “The Senate is considering the nomination of Russell Vought to be Director of the Office of Management and Budget, post cloture. If all time is used, a confirmation vote would occur at 7:00 p.m. We expect several procedural votes to follow the vote on the Vought nomination.”
“The Senate on Thursday confirmed Russell Vought as the next director of the powerful White House budget office, installing a conservative fiscal hawk who has promised to pursue sweeping spending cuts and empower President Donald Trump to conform the budget to his political views.
“Republicans marshaled a 53-47 vote in support of Vought, who immediately inherits the exceedingly complicated tasks of staving off a government shutdown and preventing a catastrophic debt default — with a political clash over the two critical fiscal deadlines just weeks away.”
“The White House is working on an executive order to fire thousands of U.S. Department of Health and Human Services workers, according to people familiar with the matter.
“Under the order, the Food and Drug Administration, Centers for Disease Control and Prevention and other health agencies would have to cut a certain percentage of employees.
“The order could come as soon as next week, people familiar with the matter said, after workers have an opportunity to take a buyout. The terms of the order haven’t been finalized, however, and the White House could still decide against going forward with the plans.
“The job cuts under consideration would affect the Department of Health and Human Services, which employs more than 80,000 people and includes the National Institutes of Health and the Centers for Medicare and Medicaid Services, in addition to the FDA and CDC.
“The agencies are responsible for a range of functions, from approving new drugs to tracing bird-flu outbreaks and researching cancer. A loss of staff could affect the efforts depending on which workers are cut and whether they are concentrated in particular areas.
‘The White House on Thursday denied that there is an executive order related to HHS coming.”
“A federal judge paused a Thursday deadline for federal employees to decide whether to accept an offer from the Trump administration to resign their jobs voluntarily as the president and his allies attempt to shrink the government workforce.
“U.S. District Judge George O’Toole in Massachusetts scheduled a hearing for Monday on whether to grant a temporary restraining order that would block the program while the litigation challenging the offer proceeds.
“Employees had previously been told they had until the end of the day on Thursday to decide whether to accept the offer.”
“The U.S. Food and Drug Administration (FDA) is warning patients with diabetes about the risk of missing critical safety alerts when using continuous glucose monitors, insulin pumps, automated insulin dosing systems and any other similar medical devices.
“While smartphones have made it easier than ever for patients to track their own insulin levels, the convenient technology is far from infallible. In fact, the FDA has received multiple reports of smartphone-compatible medical devices failing to send expected health alerts. When this happens, the agency warned, it creates a risk of patients experiencing severe hypoglycemia, severe hyperglycemia, diabetes ketoacidosis or even death.
“Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them,” Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, said in a statement. “However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected. Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
“The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.
“This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
“The Postal Service ended the first quarter of fiscal 2025 with a net profit — a rare moment in the black that Postmaster General Louis DeJoy says is evidence the agency is on the “right path” to overcome long-term financial challenges.
“USPS reported $144 million in net income for the first quarter of fiscal 2025, a dramatic reversal from the $2.1 billion net loss for the same quarter last year. The agency’s first quarter is usually its best all year.
“The last time USPS saw a net profit was in fiscal 2022, when it ended the year with a $56 billion net profit, ending a nearly 15-year streak of annual net losses.
“That sudden change, however, came from Congress passing the Postal Service Reform Act, which ended a mandate for USPS to pre-fund its retiree health benefits well into the future, and brought the agency back to a pay-as-you-go system. The legislation also forgave $57 billion in deferred payments to the retiree health fund.”
From the public health and medical research front,
The American Hospital Association News points out,
“The U.S. maternal mortality rate decreased to 18.6 deaths per 100,000 live births in 2023, down from 22.3 in 2022, according to new data from the Centers for Disease Control and Prevention. While the mortality rate decreased overall, the maternal mortality rate for Black women in 2023 was 50.3 deaths per 100,000 live births, significantly higher than rates for white (14.5), Hispanic (12.4) and Asian (10.7) women.”
“The Centers for Disease Control and Prevention Feb. 6 released an advisory about an outbreak of Ebola in Uganda caused by the Sudan virus disease. There are currently no suspected, probable or confirmed Ebola cases related to the outbreak that have been reported in the United States or outside of Uganda. The CDC recommends travelers monitor themselves for symptoms of SVD while in Uganda and 21 days after leaving.”
“Pregnant women are more likely to die of violence than any medical cause in the U.S. and are at greater risk for violent death compared with nonpregnant women, underscoring the need for intimate partner violence screening, data show.
“In an analysis of CDC mortality data presented at The Pregnancy Meeting, researchers also found that domestic violence firearm legislation was associated with a reduction in homicide and firearm death in pregnancy.”
“Kaiser Permanente and Tufts University have launched a joint initiative aimed at improving nutritional and dietary health, the organizations said Thursday.
“The Food is Medicine National Network of Excellence comprises Tufts University’s Food is Medicine Institute in Medford, Massachusetts, and Oakland, California-headquartered Kaiser, along with network members such as Blue Cross and Blue Shield of North Carolina, CVS Health, Devoted Health, Elevance Health, Geisinger Health and Highmark Health.
“Network members will track patient outcomes following nutritional and dietary changes and use the data to instruct care delivery and promote food-is-medicine initiatives, according to a news release.”
The Health Care Cost Institute (HCCI), in collaboration with West Health, conducted an analysis on the use of telehealth mental health services among people with employer-sponsored insurance (ESI). We found that telehealth played an outsized role in the delivery of mental health services starting in 2020, with over 40% of mental health visits occurring via telehealth from 2020-2022. Females, young adults, and people residing in the northeast and west coast received the highest share of mental health care via telehealth. Therapy was the most commonly received mental health service via telehealth.
The Centers for Disease Control and Prevention Feb. 6 released a report on emergency department use during the Los Angeles County wildfires that began Jan. 7. All-cause ED encounters in Los Angeles County initially decreased 9% after the start of wildfires, while wildfire-associated encounters increased eightfold. Wildfire-associated ED encounters peaked from the period of Jan. 7-12, aligning with worsened air quality deemed unhealthy for sensitive groups. The CDC said the initial decrease in all-cause visits could be due to evacuations; alterations in activity patterns; or residents seeking care in clinics, urgent care centers or EDs in neighboring counties.”
“A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing, an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “Everyone was dumbfounded,” said a scientist who was let go.
“It was one early sign that, for all the public accolades, the CRISPR revolution wasn’t exactly going according to plan.
The gene editing tool, wrested out of bacteria 13 years ago by a fractious group of biochemists, was supposed to change medicine. Excitement surged through boardrooms, patient communities, and the press. No less an authority than a Nobel Prize committee announced, in 2020, that CRISPR “may make the dream of curing inherited diseases come true.” Billions were spent chasing that vision, along with treatments for cancer and other non-hereditary diseases, such as HIV.
“Few still talk that way. They sure don’t spend that way.
“Over the last 16 months, layoffshavehitnearlyeverymajorCRISPRpublicand privatebiotech. Eight public CRISPR stocks are down roughly 50% over the past year. Most are down over 75% from their 2021 peak, when near 0% interest rates and the enthusiasm around mRNA fueled a gene editing bubble. Buzzy startups have closed or merged out of existence, sometimes thunderously. In August, Tome Biosciences collapsed, just eight months after announcing $213 million in funding from biotech’s most prestigious investors and a plan to write “the final chapter in genomic medicines.” [See STAT’s updated CRISPR Tracker here.]“
Notably, the hospital report tells us “In 2024, hospital financial and operational performance stabilized. Outpatient revenue increased, and patient observation days decreased. Though expenses in 2024 rose, they did not outpace inflation on a volume-adjusted basis.”
From Beckers Payer Issues, we learn that “KLAS Research, a healthcare IT data and insights company, named its “Best in KLAS” payer tools for 2025.”
“Molina reported mixed fourth-quarter results on Wednesday, beating Wall Street expectations on revenue but missing on earnings. The payer also laid out earnings guidance for 2025 that was lower than analysts had anticipated.
“The fourth-quarter earnings miss was due to higher medical spending in Medicaid, with no help from the risk corridors that kept the worst of utilization jumps from hitting Molina’s bottom line earlier in 2024. Meanwhile, the lower earnings forecast for this year is because of implementation costs from recent contract wins in Medicaid and for individuals dually eligible for both the safety-net program and Medicare, according to the insurer.
“The results and 2025 outlook are “disappointing at face value,” but accretion from the contract wins could set Molina up well for 2026, J.P. Morgan analyst John Stansel said in a note Wednesday.”
“Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027.
“The announcement builds on cutbacks Bristol Myers announced last April and that affected about 2,200 employees. Bristol Myers didn’t say how many workers will be impacted by the new initiative, but Chief Financial Officer David Elkins told analysts on a conference call that cuts will drive “operational efficiencies across multiple areas of the business.”
“Bristol Myers is already facing limited generic competition for one of its highest-grossing products, the multiple myeloma drug Revlimid. But it’s also bracing for the loss of billions in yearly revenue when patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The planned cuts announced Thursday will help Bristol Myers become a “leaner, more focused company” along the way, CEO Chris Boerner said.”
“Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell in line with analyst expectations.
“Bristol Myers Squibb, which acquired Cobenfy through its $14 billion purchase of Karuna Therapeutics, gave a first look at the medicine’s launch in an earnings report released Thursday. Cobenfy comes as a capsule. It received Food and Drug Administration approval on Sept. 26 as a treatment for schizophrenia, then launched onto the U.S. market in late October.
“By Bristol Myers’ count, the number of filled Cobenfy prescriptions had climbed to around 1,000 per week by the end of January. Chief Commercial Officer Adam Lenkowsky told investors on an earnings call that the “launch is really off to a strong start” and the company has “made very good progress achieving our access goals.”
“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.”
“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.
“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.”
“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.”
“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.”
“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.”
“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,
“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.
“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.
“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.”
“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.”
“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.”
Prospect Medical Holdings said Monday it has a deal to sell its twohospitals in Rhode Island — collectively called CharterCARE Health Partners — for approximately $160 million to the Centurion Foundation, a nonprofit healthcare operator based in Georgia.
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.
“Robert F. Kennedy Jr.’s chances of confirmation as Health and Human Services secretary appeared to hinge Thursday on convincing a handful of Senate Republicans that he would adhere to accepted science when it comes to vaccines. * * *
“Three key Republicans pressed the prominent vaccine critic to moderate his past positions and unequivocally endorse vaccinations, starting with HELP Committee Chair Dr. Bill Cassidy (R-La.). Cassidy likewise challenged Kennedy during the Senate Finance Committee’s confirmation hearing Wednesday.
“Cassidy declined to declare support for President Donald Trump’s nominee to be the nation’s highest-ranking health official during the hearing or when questioned afterward. GOP Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska) also have not declared support for Kennedy.” * * *
“Kennedy could lose up to three Republicans and still be confirmed. The nominee needs 51 votes, and Republicans have a 53-47 advantage over Democrats in the Senate. If necessary, Vice President JD Vance would break a 50-50 tie in his constitutional capacity as president of the Senate.
“If Cassidy, Collins, Murkowski and McConnell all vote nay, Kennedy would be one vote short, assuming every Democrat opposes him. Yet a few Democrats have not declared their positions on the nominee, such as Sens. Cory Booker (N.J.) and John Fetterman (Pa.).
“The Finance Committee will vote whether to recommend confirmation to the Senate, while the HELP Committee will not. The Finance Committee vote has not been scheduled but may come as soon as next week. Cassidy sits on the Finance Committee, while Collins, Murkowski and McConnell do not.”
“Senate Budget Committee Republicans approved Russ Vought’s nomination to serve as President Donald Trump’s budget director on Thursday, overcoming the absence of Democrats on the panel who boycotted the markup.
“The 11-0 party-line vote clears the way for Vought’s nomination to go to the full Senate. The Senate Homeland Security and Governmental Affairs Committee, which shares jurisdiction over the Office of Management and Budget, approved Vought’s selection in a party-line vote last week.
“Thanks to Democrats’ boycott, Republicans had to wait for all 11 GOP panel members to trickle in from their other obligations due to rules requiring a quorum of committee members before taking a vote.”
“The Office of Personnel Management is sharing initial details with internal employees on what the federal return-to-office mandate will look like for OPM’s own staff members.
“Starting March 3, OPM employees are expected to report to work on-site full-time, OPM Acting Director Charles Ezell told employees Wednesday evening in an all-staff email, obtained by Federal News Network.
“Ezell described his email as a “preview” of the agency’s return-to-office plans, adding that OPM will host a town hall next week to share more details with employees.
“As with any operational change, we know we will encounter challenges, but I am confident that you will bring the same diligence and innovation to this process as you have countless other efforts we have undertaken at OPM,” Ezell wrote in the email to OPM employees.
“Ezell’s email comes in response to a Jan. 23 memo outlining how agencies are expected to respond to President Donald Trump’s directive to end remote work in the federal workforce. The OPM guidance clarified that the mandate applies to both teleworkers and remote workers, but that there are exemptions for employees with disabilities, qualifying medical conditions or other “compelling reasons.”
“Emerging return-to-office plans may vary by agency, but agencies in the executive branch are expected to similarly issue implementation plans to return their employees to the office full-time.”
Tammy Flanagan, writing in Govexec, offers advice figuring out the Fork in the Road program.
“The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals.
“The culmination of decades of work, Vertex’s Journavx is now cleared to treat the short-lived “acute” pain usually felt after an accident or a surgery. Vertex hopes to eventually get the drug approved for chronic pain as well, though clinical trials testing it in that setting have produced mixed results.
“Acute pain is often treated with a combination of acetaminophen, anti-inflammatory agents like ibuprofen and, if necessary, opioids, which pose an addiction risk because they act directly on the brain and stimulate pleasure centers. Despite the dangers, insurance companies, pharmacy managers and drugmakers like Purdue Pharma for years pushed forthe use of opioids in pursuit of immense profits. The resulting overdose crisis has killed hundreds of thousands of people in the U.S. alone.”
“An organization representing Medicare Advantage insurers is asking CMS to pause any policy changes to the program not required by law in 2026.
“In a Jan. 28 press release, the Better Medicare Alliance, a pro-MA group backed by several major insurers, urged the agency to prioritize “stability” in its 2026 proposed rule.
“In November, the Biden administration pitched several major regulatory changes for 2026, including requiring Medicare to cover GLP-1 drugs for individuals with obesity.”
From the public health and medical research front,
Scores in complex attention, executive function, and memory improved.
Women versus men and people ages 55-65 versus 66-77 benefited more from the program.
Per Fortune Well,
“The myth that cannabis is harmless because it’s natural has been further debunked—by scientists in a pot-friendly state. New research from the University of Colorado Anschutz Medical Campus shows that heavy lifetime cannabis use may harm working memory in young adults.
“In what the university calls the largest study of its kind, researchers used brain imaging technology to explore the effects of recent and lifetime cannabis use on brain function among more than 1,000 people ages 22 to 36. During a task assessing working memory—the short-term storage of information that can be applied to activities such as reasoning and problem-solving—the majority of recent (68%) and heavy lifetime (63%) cannabis users showed reduced brain activity. The findings were published Jan. 28 in the journal JAMA Network Open.”
“How many times a day do you touch your phone? It’s pretty easy to lose count, as it seems like our cell phones never leave our side—even when we use the bathroom. You might want to rethink your toilet doom scrolling, though, as your phone can be one of the worst breeding grounds for fecal bacteria and other viruses.
“Several studies of health care workers show the high level of bacterial and microorganism growth on their mobile phones—but it’s not just in clinical settings that bacteria thrives on smartphones. A 2017 study of high school students’ phones found the presence of over 17,000 bacterial gene copies per phone—the more gene copies, the greater potential for faster bacteria growth.
“Most jarringly, researchers at the University of Arizona found that cell phones carry 10 times more bacteria than a toilet seat, including E.coli, Salmonella, norovirus, staph, and gonorrhea. That can add up to a lot of bacterial exposure, as a Reviews.org survey reports that Americans check their phones a whopping 205 times a day.
“People’s phones are out when urinating and defecating, exposing the phones to bacteria,” says Dr. Suraj Saggar, chief of infectious disease at Holy Name Medical Center in New Jersey. “Then put it into a pocket or purse that is dark, allowing bacteria to grow.”
“[In the article], experts tell Fortune how worried you should be about potential pathogens on your phone and the best way to keep it clean.”
“Cigna closed out 2024 on shaky footing, posting fourth-quarter results below Wall Street’s expectations due to a rise in medical costs. Meanwhile, top executives pledged changes to medical and pharmacy plans amid widespread discontent with health insurance companies.
On Thursday, the Connecticut-based company reported revenue of $65.7 billion, up 29% year over year, and income of $1.4 billion, up 38% year over year. However, adjusted income from operations, which Cigna believes is a better metric of how the company performs, fell 8% year over year to $1.8 billion, well below analyst forecasts.
Cigna CEO David Cordani told investors Thursday morning the company will work to make receiving medical and pharmacy care cheaper and easier for its customers, amid criticism that insurers and pharmacy benefit managers are profiteering at the expense of the American consumer.”
“Cigna’s health benefits division spent 87.9% of premium revenue on medical expenses in the fourth quarter, more than analysts were expecting from that key measure. Management blamed it on “stop loss” plans, which employers use to guard against costly medical claims.
“Cigna’s management said the problem was increased use of cancer drugs like Keytruda, which is priced at around $200,000 a year, and multiple sclerosis treatment Ocrevus, listed at around $80,000 annually. Expensive hospital stays for cancer and heart surgeries also drove up medical spending, management said.”
“Cigna executives said that the company is on track to close the sale of its Medicare Advantage business in the first quarter of 2025, in line with its expectations.
“The insurer announced plans to sell off its MA plans to Health Care Service Corporation in January 2024 in a deal valued at $3.7 billion. Chief Financial Officer Brian Evanko said that all federal antitrust approvals have been received, as have all but one state approval.”
“Zimmer Biomet has agreed to buy Paragon 28, an orthopedics company focused on foot and ankle implants, for an equity value of approximately $1.1 billion.
“Zimmer will purchase all outstanding shares of Paragon 28 for $13 per share, according to the Tuesday announcement. The amount is a slight premium over Paragon’s Tuesday closing price of $12; however, its shares fell below $5 as recently as October. The deal is expected to close in the first half of 2025.
“Needham analysts, in a Wednesday note to investors, wrote they have viewed Paragon as a potential acquisition target for a long time and were “surprised by the small premium that [Zimmer] is paying.” The analysts expect Zimmer to pull off more acquisitions, potentially outside of orthopedics.”
“Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
The American Hospital Association (AHA) News tells us,
The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being.
“A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
“More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
“Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
“About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
“The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
“The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule.
“The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
“Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”
From the public health and medical research front,
In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis.
While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
“988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association.
Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners.
The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
Vitamin C also delayed the impact of adverse events and improved quality of life.
“Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
“These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”
“A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
“The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
“We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
“Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs.
“Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release.
“Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.”
“Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
“Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
“Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
“The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
“This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’sLLY Zepbound and Novo Nordisk’sNOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half.
This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”
“The White House’s Office of Personnel Management sent an email blast Tuesday to civilian government employees offering them an easy way to quit with pay through Sept. 30, the most sweeping effort yet by the new Trump administration to shrink the ranks of the federal workforce.
“The email instructed employees to reply to the message saying they want to resign if they would like to take the offer,which would provide the incentive for workers who accept by Feb. 6, said an Office of Personnel Management spokesperson. Not all employees will be eligible, according to the spokesperson, who said some of the exemptions will be up to agency heads. Additional carveouts exist for immigration officers, some people in national security-focused roles, the Postal Service and the armed forces, the spokesperson said.”
Here is a link to OPM’s FAQs on its “Fork in the Road” program.
“Federal employees have filed a lawsuit against the Trump administration’s Office of Personnel Management, after the agency created and began testing an email system meant to deliver mass communications directly to federal employees’ inboxes.
“The lawsuit from two anonymous federal employees in the executive branch alleges OPM violated the 2002 E-Government Act by not releasing details of how the communication system will manage federal employees’ personal information stored in the system.
“Kel McClanahan, executive director of the National Security Counselors law firm, filed the pro bono lawsuit on behalf of the plaintiffs, alleging that the email system poses security risks for federal employees’ personal information.”
“President Donald Trump’s pick to oversee much of the federal government’s real estate portfolio is looking to significantly downsize the amount of office space that agencies occupy.
“Michael Peters, commissioner of Public Buildings Service within the General Services Administration, said the agency is looking at cutting up to half its total real estate portfolio over the coming years.
“I’m just getting ramped up, but I think our initial review says that number could be up to a 50% reduction on our square footage across the portfolio. We’re not going to do that in six months, but we’re going to try to do this as rapidly as we can,” Peters said Tuesday.
“Peters said a “disproportionate amount of that space” would come from the Washington, D.C. metro area — and will include GSA moving out of its own 1800 F Street headquarters.”
The President issued an executive order today announcing, “the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called “transition” of a child [including teenagers under age 19] from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
With respect to the FEHB Program
“The Director of the Office of Personnel Management, as appropriate and consistent with applicable law, shall:
“(a) include provisions in the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs call letter for the 2026 Plan Year specifying that eligible carriers will exclude coverage for pediatric transgender surgeries or hormone treatments; and
“(b) negotiate to obtain appropriate corresponding reductions in FEHB and PSHB p premiums.”
“The Center for Medicare and Medicaid Innovation is continuing plans to implement a pilot project testing new ways for state Medicaid programs to pay for multimillion-dollar cell and gene therapies.
“President Trump’s Executive Order never rescinded the work that was underway by the CMS Innovation Center on drug models,” a Department of Health and Human Services spokesperson said in an email to STAT.
“The pilot addresses an existential issue for state Medicaid programs: how to pay for cell and gene therapies that are highly effective, but expensive, on fixed budgets.
“Two drug manufacturers that make treatments for sickle cell disease are participating: Bluebird Bio, which makes Lyfgenia, and Vertex Pharmaceuticals, which makes Casgevy. Lyfgenia’s list price is $3.1 million, and Casgevy’s list price is $2.2 million.”
“Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients.
“Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, the company said Tuesday.
“The approval makes Ozempic the most broadly indicated GLP-1 drug on the market, the Bagsvaerd, Denmark, company said. The FDA approved semaglutide for weight loss under the brand name Wegovy in 2021.”
“The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer.
Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of the HER2 protein. With its new decision, the agency widened Enhertu’s availability to include treatment of tumors with “ultralow” HER2 expression. HER2 protein levels must be determined by an FDA-approved test, AstraZeneca and Daiichi said in a statement.”
From the public health and medical research front,
“A new strain of avian influenza has been identified for the first time in the United States, raising concerns that the virus is transforming in a way that could eventually cause wider outbreaks among humans.
“U.S. officials disclosed the discovery of the virulent H5N9 strain at a California duck farm in a report in recent days to the World Organization for Animal Health, which maintains a database of animal disease threats.
“That disclosure comes as the United States confronts a growing outbreak of another bird flu strain, H5N1, that is spreading in poultry farms across the nation and hasinfected dairy cows for the first time. Human cases have been sporadic and confined mostly to dairy workers exposed to sick animals.
“The H5N9 strain itself does not pose a grave threat to humans, officials and experts said.”
“Dementia cases in the U.S. are expected to double by 2060, reaching 1 million new cases per year, according to a study released Jan. 13 by NYU Langone Health. The study found that the risk of developing dementia any time after age 55 is 42%, more than double the risk reported in prior studies. The study authors attributed previous underestimates of dementia risk to unreliable documentation in health records and on death certificates, minimal surveillance of early-stage dementia cases and underreporting of cases by race.”
“Rates of sudden unexpected infant death in the United States increased by nearly 12 percent from 2020 to 2022, according to new research published on Monday in the journal JAMA Pediatrics.
“Though the study offered some good news — overall infant mortality rates dropped by 24 percent from 1999 to 2022 — it also raised questions about why more babies appear to be dying during sleep, and why rates of sleep-related death remain notably higher among Black, Native American and Pacific Islander babies than among white and Asian infants.
“Dr. Elizabeth Wolf, an associate professor of pediatrics with Children’s Hospital of Richmond at Virginia Commonwealth University who was among the new study’s authors, called the findings “pretty alarming.”
“The death of an infant from SIDS or SUID is unbelievably horrific,” Dr. Wolf continued, using two acronyms that describe sleep-related deaths among infants. “And we as a public health community need to do everything we can to try and reduce the risk factors as much as possible.”
“Cannabis use is on the rise throughout the United States, but it is not as harmless as some people may believe. In fact, according to a new in-depth analysis in Nature Reviews Cardiology, regular cannabis use increases a person’s risk of multiple adverse cardiovascular outcomes, including myocardial infarction, arrhythmias and cardiomyopathy.[1]
“The study’s authors, a group of researchers with the Stanford Cardiovascular Institute, explored a wide variety of topics, including ongoing policy trends related to cannabis and the science behind why it appears to make such a significant impact on the cardiovascular system. The group also emphasized that it will be important to learn more about the long-term impact of cannabis use as time goes on.
“Cannabis is emerging as a risk factor for adverse cardiovascular health,” wrote first author Mark Chandy, MD, PhD, who is now an assistant professor at Western University in Ontario, Canada, and colleagues. “With changing public perceptions and an overall decline in tobacco use, cannabis is poised to replace tobacco as a legal drug of choice. Previous restrictions are ending with the widespread decriminalization and legalization of cannabis, boosting use of the drug. A public perception that cannabis is harmless and therapeutically beneficial persists, despite mounting evidence from preclinical and clinical studies showing that cannabis use can harm the cardiovascular system and pose other serious health problems, not unlike tobacco.”
“Cedars-Sinai experts are advocating for patients to have access to GLP-1 medications such as semaglutide as a key component to caring for and preventing cardiovascular disease.
“Physicians are now able to improve multiple “downstream” conditions, such as heart disease, by prescribing one medication “upstream,” according to a Jan. 10 news release from Los Angeles-based Cedars Sinai.
“Amanda Velazquez, MD, director of obesity medicine at the health system, said in the release that semaglutide has enabled patients with high blood pressure to reduce their antihypertensive medications.
“Martha Gulati, MD, director of preventive cardiology and the Anita Dann Friedman Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai, said although semaglutide has been associated with blood pressure and cholesterol level improvements, it does not replace statins.
‘Dr. Gulati also said the effectiveness of the drug class raises the important question: “Do we want patients to get CVD and only then treat them? Or should we treat them earlier so we can prevent CVD events?”
The Wall Street Journal discusses “The Scientific Fight Over Whether Aging Is a Disease.”
“Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year.
“The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration’s support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year’s median price increase was 4.5%.”
“The National Community Pharmacists Association (NPCA) is warning the feds that independent pharmacists are likely to face significant financial hardship due to Medicare drug price negotiations.
“In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products.
“The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps.
“The NCPA said this is because they’re concerned about “financial losses” through the program.
“That will be devastating to the program,” said NCPA CEO B. Douglas Hoey in a press release. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program.'”
“In less than a year, Mark Cuban’s Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines.
‘Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities.
‘Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe.
“The Marketplace now sells to thousands of hospitals, clinics, ambulatory surgery centers, long-term care sites, dialysis centers and retail pharmacies in all 50 states, Mr. Bowe told Becker’s Jan. 23.”
Beckers also brings us up to date on current drug shortages.
CVS Health is rolling out a new customer app that aims to make it simpler and more convenient for users to manage health benefits, pharmacy benefits and prescriptions.
Within the application, users can monitor prescriptions for themselves as well as family members across CVS’ pharmacies, Caremark mail orders and CVS Specialty. This includes “full transparency” into the status of a prescription order and the cost, CVS said.
In addition, users can schedule key immunizations for their entire family, and access spending and benefits details from both Aetna and Caremark through the app.
“UNC Health and Duke University Health System, based in Chapel Hill, N.C., and Durham, N.C., respectively, are uniting to build a comprehensive healthcare campus, featuring the state’s first freestanding children’s hospital.
“The two institutions filed legal documents Jan. 28 with the state to establish a nonprofit entity, North Carolina Children’s, according to a joint news release.
NC Children’s will feature a 500-bed children’s hospital on a 100-plus-acre campus at a yet-to-be-identified site in the Research Triangle region.
“The new campus will also include a children’s behavioral health center, outpatient clinics, research and teaching facilities, hospitality houses (e.g., Ronald McDonald House) and mixed-use infrastructure to accommodate hotels, restaurants and retail stores, according to the release.”
“A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
“On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
“Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
“And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
“Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
“Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
“I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
“Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
“Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
“Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response.
“Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
“The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration.
“A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.
“A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
“The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM.
“The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
“Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
“And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
“In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
“The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
“Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department.
“The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
“The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.”
“The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
“The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”
From the public health and medical research front,
The Center for Disease Control and Prevention announced today,
Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
COVID-19
COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
Influenza
Seasonal influenza activity remains elevated across the country and is increasing in many areas.
RSV
RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
Vaccination
Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
“An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.
‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
“Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
“The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.
“Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
“I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
“Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health.
GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan.
“Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.”
“Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
“AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
“The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
“Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
“Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.”
“Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
“Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
“He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
“Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
Mental health conditions remained the leading telehealth diagnostic category nationally and regionally.
The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.
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