• President Joe Biden signed a bill into law that orders the Director of National Intelligence to declassify information on the origins of the COVID-19 pandemic, saying that he plans to “share as much of that information as possible, consistent with my constitutional authority to protect against the disclosure of information that would harm national security.” (Politico) Meanwhile, a new analysis of data shows a potential connection between the COVID-19 virus and animals sold at a market in Wuhan, China, a report that some researchers say offers the strongest evidence yet that the coronavirus jumped from animals to humans. (Bloomberg)
• Moderna Inc. Chief Executive Stéphane Bancel plans to tell the Senate Health, Education, Labor and Pensions committee during a hearing tomorrow that the pharmaceutical company has paid the federal government more than enough for the partnership that developed its COVID-19 vaccine. Moderna President Stephen Hoge said in an interview that the company believes it has paid the government back “and then some,” noting that the government discount led to it making about $3 billion less in sales than rival Pfizer Inc. (Bloomberg)
• The Centers for Disease Control and Prevention warned that cases of the drug-resistant fungus Candida auris are increasing at an “alarming” rate in U.S. health facilities, with 30 states and the District of Columbia now having reported infections. The number of cases increased from 756 in 2020 to 1,471 in 2021 after only a few dozen were reported each year since the first reported American case in 2016, and preliminary figures show at least 2,377 additional cases last year. (CBS News)
• The House Oversight and Reform and Energy and Commerce committees are investigating a data breach of a third-party subcontractor with the Centers for Medicare and Medicaid Services that exposed the identifiable data of 254,000 Medicare beneficiaries. Republican leaders want CMS to provide more information on the matter after the agency did not report the October 2022 breach to Congress until December 2022. (Bloomberg Law)

Worth watching today:

• Urban Institute event: “Unequal Treatment at 20: Accelerating Progress toward Health Care Equity.” Speakers include Health and Human Services Secretary Xavier Becerra and Robert Otto Valdez, director of the Agency for Healthcare Research and Quality.
• Kaiser Family Foundation web event: “Unpacking the Controversy Over Medicare Advantage.”

Nearly 1 in 3 patients don’t see primary care doc

Axios

‘We Were Helpless’: Despair at the C.D.C. as the Pandemic Erupted

Apoorva Mandavilli, The New York Times

Current and former employees recall rising desperation as Trump administration officials squelched research into the new coronavirus.

8 burning questions Bernie Sanders and other senators should ask Moderna’s Stéphane Bancel

Helen Branswell, Stat News

Bancel will appear alone before Sen. Bernie Sanders’ health committee on Wednesday, where he’ll have to defend his company’s suggestion it will likely quadruple the price of its Covid vaccines once sales transition from bulk federal purchases to the open market.

Ignoring experts, China’s sudden zero-COVID exit cost lives

Dake Kang, The Associated Press

Chinese state media claimed the decision to open up was based on “scientific analysis and shrewd calculation,” and “by no means impulsive.” But in reality, China’s ruling Communist Party ignored repeated efforts by top medical experts to kickstart exit plans until it was too late, The Associated Press found.

Some Gerber Baby Formula Recalled Due to Possible Contamination

Colin Kellaher, The Wall Street Journal

Perrigo said it is recalling the formula out of an abundance of caution because of the potential presence of Cronobacter sakazakii, a bacteria commonly found in the environment that causes no symptoms in most people but can lead to poor feeding, excessive crying or low energy in premature infants, infants under 2 months of age or infants with weakened immune systems.

Lawmakers probe whether organ procurers are ‘gaming’ the system

Lenny Bernstein, The Washington Post

The Senate Finance Committee, which has been scrutinizing the U.S. transplant system for three years, sent letters to ten organ procurement organizations on Monday seeking data on whether they have been collecting vastly increased numbers of human pancreases for research when there is no apparent need for the organs. The letter suggests they may be using this “loophole” to “falsely inflate their performance.”

Senator calls for probe of conflict of interest on federal panel overseeing dietary guidelines

Ed Silverman, Stat News

The 20 members of the panel are academics and physicians who have backgrounds in nutrition and public health. But one panelist — Fatima Cody Stanford, an obesity specialist at Massachusetts General Hospital in Boston — was also paid nearly $27,000 for consulting and speaking by Novo Nordisk and another $2,250 by Eli Lilly in recent years, according to a federal government database.

Most doses of Novo Nordisk’s Ozempic are removed from FDA drug shortage list after supply issues

Nicole DeFeudis, Endpoints News

Novo Nordisk’s type 2 diabetes treatment Ozempic, which is also used off-label for weight loss, is back in stock following a months-long shortage, according to the FDA’s drug shortages list.

DEA issues alert about widespread threat of xylazine

Janelle Chavez, CNN

The US Drug Enforcement Administration issued an alert Monday about the widespread threat of fentanyl mixed with xylazine, a veterinary tranquilizer also commonly known as “tranq” or “tranq dope.”

With overdoses up, states look at harsher fentanyl penalties

Gabe Stern et al., The Associated Press

Imposing longer prison sentences for possessing smaller amounts of drugs represents a shift in states that in recent years have rolled back drug possession penalties. Proponents of tougher penalties say this crisis is different and that, in most places, the stiffer sentences are intended to punish drug dealers, not just users.

Some Roadblocks to Lifesaving Addiction Treatment Are Gone. Now What?

Martha Bebinger, WBUR

The federal government has lifted restrictions on one of the most effective opioid addiction treatment medications. The change sets up a “truth serum moment”: Will mainstream doctors and nurses now treat addiction as a common disease?

Missouri takes aim at gender affirming care for youth

Sareen Habeshian, Axios

Missouri Attorney General Andrew Bailey announced that his office is issuing an emergency regulation “clarifying that, because gender transition interventions are experimental,” they are prohibited under state law.

Higher Health Costs Foreseen From Revamped Billing Disputes

Sara Hansard, Bloomberg Law

Health insurers, employers, and consumers could see higher costs in the wake of Biden administration guidance on settling payment disputes for emergency and out-of-network care, an official with a consumer group said.

HHS Pushed to Scrutinize States on Medicaid Eligibility Checks

Ganny Belloni, Bloomberg Law

A letter sent Monday by the Congressional Tri-Caucus, a coalition composed of the Congressional Hispanic Caucus, the Congressional Asian-Pacific American Caucus, and the Congressional Black Caucus, urged HHS Secretary Xavier Becerra to take steps to police states not doing enough to prevent Medicaid coverage loss due to administrative inefficiency and red tape.

Medicaid renewals are starting. Those who don’t reenroll could get kicked off

Maria Godoy, NPR News

With a pandemic-era rule expiring this month, people on Medicaid will have to re-qualify to keep their coverage. Language barriers, housing instability and computer literacy could stand in their way.

Medicare Advantage marketing was different in 2023. That’s no accident.

Nona Tepper, Modern Healthcare

Industry giants UnitedHealthcare and Humana dominated the private Medicare market for the current plan year, capturing more than 70% of new enrollees and far outpacing the average industry growth rate of 7%. These leading insurers strengthened their positions by adapting to new regulatory and marketplace realities.

MACPAC calls for states to have power to restrict Medicaid coverage of some accelerated approval drugs

Robert King, Fierce Healthcare

One of the key recommendations is to limit state coverage under Medicaid of drugs cleared via accelerated approval that have not completed a confirmatory trial. The recommendation is the latest tension point between Medicare and Medicaid regulators and the accelerated approval pathway.

Highmark Medicare Advantage enrollment grows 12%

Nona Tepper, Modern Healthcare

Policies co-branded with providers, tailored benefit offerings and high star ratings drove up enrollment 29,000 to 345,000, Highmark Health Plan President Tom Doran said during a call with investors Monday. Highmark Health Plan currently covers 7 million commercial, exchange, Medicaid and Medicare members in Delaware, New York, Pennsylvania and West Virginia.

Millions of Children on Medicaid at Risk of Losing Coverage

Ganny Belloni, Bloomberg Law

The ranks of Medicaid beneficiaries grew by nearly 20 million people as the program acted as a health insurance safety net. However, the Consolidated Appropriations Act of 2023 slowly unwinds the federal continuous coverage requirement through May 2024, allowing states to start eligibility redeterminations next month for all 83.5 million Medicaid beneficiaries — including more than 34.2 million children.

Drug shortages upend hospitals care, cancer treatments

Tina Reed, Axios

Supplies of some essential drugs used in hospitals are hitting 10-year lows, forcing rationing and pharmacy workarounds. Drug shortages are the worst they’ve been in a decade, according to the American Society of Health-System Pharmacists — a sign of how much we rely on low-margin manufacturers with limited capacity for basics like the inhalation drug albuterol and some common cancer treatments.

Mental Health Care by Video Fills Gaps in Rural Nursing Homes

Tony Leys, Kaiser Health News

In-person mental health care is hard to arrange in rural nursing homes, so video chats with faraway professionals are filling the gap.

MedPAC in no rush to recommend major hospital Medicare payment increases, despite industry’s pleas

Dave Muoio, Fierce Healthcare

With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals has already criticized for “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system and outpatient prospective payment system rules.

FDA staff says Biogen’s ALS drug may have a ‘clinical benefit’ on a rare form of the disease

Annika Kim Constantino, CNBC

U.S. Food and Drug Administration staff on Monday said Biogen’s investigational ALS drug may have a “clinical benefit” on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year.

Top FDA official: Agency needs to start using accelerated approval for gene therapies

Jason Mast, Stat News

A top Food and Drug Administration official said Monday that the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare disease.

Drugmaker Data, Price Negotiation Timeline Tee Up Fight With HHS

Celine Castronuovo and Ian Lopez, Bloomberg Law

The pharmaceutical industry is being cornered into negotiating lower prices than it may see fit, with little recourse under newly proposed guidance by the Biden administration, industry analysts and legal experts say.

A sign of what’s coming? Presidential hopeful DeSantis targets PBMs and pharma transparency

Zachary Brennan, Endpoints News

As the 2024 presidential election race heats up and cutting drug costs becomes a centerpiece of President Joe Biden’s policy successes to date, Republican hopeful Ron DeSantis has offered up a sign of his own plans for the industry. DeSantis is calling for all proposed drug price increases to be pre-announced by manufacturers, who would also have to submit an annual report justifying those increases.

Gilead scoops up Nurix’s IRAK4 degrader for up to $445M, plucking first fruit grown from 2019 collab

Max Bayer, Fierce Biotech

The decision gives Gilead exclusive rights to Nurix’s IRAK4 degrader, NX-0479, in exchange for $20 million in upfront cash and with $425 million in biobucks on the table, according to an announcement Monday. It’s the first target that Gilead has signed onto stemming from a June 2019 agreement with Nurix, with Gilead offering up to $2.35 billion in exchange for five protein degrader targets.

BioNTech to pay $200M upfront in CTLA-4 antibody development, commercialization deal

Paul Schloesser, Endpoints News

BioNTech and OncoC4 put out word Monday that they had reached an exclusive deal to co-develop and co-commercialize OncoC4’s monoclonal antibody candidate for a variety of cancer indications.

Karuna’s treatment for schizophrenia achieves study goals, bolsters FDA filing plans

Adam Feuerstein, Stat News

The company intends to file a marketing application for its drug, called KarXT, with the Food and Drug Administration by the middle of the year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.

AstraZeneca hit by marketing breaches across its respiratory drug range amid online slip-ups

Ben Adams, Fierce Pharma

A healthcare professional in the U.K. complained to the Prescription Medicines Code of Practice Authority, which polices the U.K.’s voluntary pharma code of marketing ethics from the Association of the British Pharmaceutical Industry, that AstraZeneca had made a series of increasingly serious errors and omissions when talking about its franchise of respiratory medicines online.

Biotech company Illumina pushes back against Carl Icahn’s proxy fight over $7.1 billion Grail deal

Annika Kim Constantino, CNBC

The San Diego-based DNA sequencing company released its latest response to Icahn’s sharp criticism of the $7.1 billion deal it completed in 2021, saying it’s committed to maximizing shareholder value as it works with antitrust regulators to “define GRAIL’s path forward as expeditiously as possible.”

This biotech’s ‘Microsoft’ approach could change how we see gene therapy

Karissa Waddick, PharmaVoice

The company’s using a unique component-based platform to develop functional cures for diseases, including HIV.

Microsoft, Nuance introduce ChatGPT successor to healthcare

Brock E.W. Turner, Modern Healthcare

Nuance introduced its new application on Monday morning called Dragon Ambient eXperience Express. The company said this version of Dragon can summarize and enter conversations between clinicians and patients directly into electronic health record systems using OpenAI’s GPT-4 generative AI capabilities.

Maven Clinic picks up digital health startup Naytal to boost growth in the UK, Europe

Heather Landi, Fierce Healthcare

Founded in 2021 by entrepreneur Leila Thabet, Naytal provides on-demand access to women’s and family health experts to support a broad range of reproductive healthcare needs, from fertility and pregnancy to postpartum care and menopause.

Ascertain’s predictive AI preeclampsia algorithm marks continued focus on femtech amid cooling markets

Annie Burky, Fierce Healthcare

Northwell Health and Aegis Ventures’ company Ascertain announced a new algorithm for predicting preeclampsia tackling worsening maternal mortality rates. As test cases of the algorithm begin to form and the industry continues to feel the ripple effects of the Silicon Valley Bank fallout, Ascertain and Aegis Ventures executives say venture capitalism will continue to fund femtech advancement.