From Washington, DC,

Capitol Hill News

• Modern Healthcare reports,
  • “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 Journal letter 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.”

• STAT News informs us,
  • “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.” 

White House News

• The AHA News lets us know,
  • “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.

• Per Govexec,
  • “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 Washington Post reports,
  • “The Trump administration is giving federal agencies until 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.”

• Bloomberg Law informs us,
  • “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.”

CMS News

• Fierce Healthcare notes,
  • “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.”
• and
  • “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.”

Food and Drug Administration News

• The New York Times relates,
  • “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,

• The Wall Street Journal reports,
  • “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.”

• CBS News points out,
  • “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 CDC’s latest data come as much of the U.S. is finally seeing signs of a slowdown in influenza activity after waves of illness this past fall and winter that climbed to the worst rates recorded from hospitals and doctor’s offices since the 2009 swine flu pandemic.”

• 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.”

• Health Day adds,
  • “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.”

• Per Healio,
  • “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 The American 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.”
• and
  • “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“

• BioPharma Dive lets us know,
  • “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.”

From the U.S. healthcare business front,

• The Wall Street Journal reports,
  • “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.
  • “The announcement, by one of the country’s biggest drugmakers, is the latest by a company outlining a major capital push in the U.S. while President Trump seeks to revive domestic manufacturing.
  • “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.”

• Per Modern Healthcare,
  • “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.”
• and
  • “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.”

• Tech Target discusses “How healthcare consumerism is driving provider revenue growth.”
  • “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.”