Health
|
Essential health care industry news & intel to start your day.
|
April 13, 2023
|
|
|
Today’s Top News
-
The U.S. Fifth Circuit Court of Appeals temporarily blocked a ruling from a federal judge in Texas that suspended the Food and Drug Administration’s approval of the abortion pill mifepristone, allowing the drug to remain on the market for now. However, the appeals court did not overturn other parts of last week’s ruling that blocked policies that expanded the access to mifepristone, including a 2016 approval to allow the drug to be used through 10 weeks of pregnancy instead of seven, and an FDA policy change this year that allows retail pharmacies to offer the medication. (The Washington Post)
- The White House proposed a federal rule that would prohibit health care organizations from sharing personal medical care records with law enforcement and state officials for investigations on reproductive care in states where abortion is legal, a move to protect the identity of women who travel across state lines to get the procedure. (The Associated Press) All 23 Democrats on the House Energy and Commerce Committee have demanded an immediate hearing on the mifepristone ban, writing in a letter to Chair Cathy McMorris Rodgers (R-Wash.) that the committee and Americans “must understand the impact of this decision and what is at stake for not only abortion care, but also for access to critical safe and effective medications more broadly.” (CNBC)
- President Joe Biden is expected to announce today that the administration is expanding eligibility for Medicaid and health insurance plans offered through the Affordable Care Act exchanges to hundreds of thousands of people who are part of the Obama-era Deferred Action for Childhood Arrivals program, two U.S. officials familiar with the matter said. (The Associated Press) Meanwhile, the Senate Health, Education, Labor and Pensions Committee is delaying its action on health care priorities slightly but is expected to eventually mark up legislation that lobbyists and staffers say has bipartisan support, including measures on generic drugs and pharmacy benefit managers. (Stat News)
- Juul Labs Inc. has agreed to a $462 million settlement with six states and Washington, D.C., to resolve lawsuits alleging that the company aggressively targeted young people while marketing its e-cigarettes. So far, Juul has reached settlements with 47 states and territories and 5,000 individuals and local governments, costing the company nearly $3 billion. (The New York Times)
Worth watching today:
|
|
|
|
|
|
|
A MESSAGE FROM MORNING CONSULT |
|
|
|
What Else You Need to Know
|
|
|
Unpacking the flawed science cited in the Texas abortion pill ruling
Lauren Weber et al., The Washington Post
Texas judge ignored scientific evidence of abortion pill’s safety, citing statistics that overstate the negative physical and psychological effects of mifepristone.
Abortion pill ruling puts ‘judge shopping’ concerns back in spotlight
Kevin Breuninger, CNBC
A pivotal fight over the Food and Drug Administration’s approval of the abortion pill mifepristone has spurred new accusations of “judge shopping” by plaintiffs seeking a favorable audience for their litigation. The legal battle over the abortion pill has largely taken place in Amarillo, Texas, home to a federal court division with just one district judge, Matthew Kacsmaryk.
Abortion ruling adds to growing GOP discontent with FDA
Maya Goldman et al., Axios
Republican frustrations with the FDA have been building for a long time — making the likely backlash even more intense if they don’t like the agency’s reaction to the court decision revoking its approval of a widely used abortion pill.
Abortion pill access may continue even if FDA loses US court battle
Tom Hals, Reuters
The contradictory rulings may give the FDA reason to preserve the status quo while the government’s appeal proceeds and declare that drug companies and doctors won’t face legal risks for making or prescribing mifepristone, experts said.
How a federal judge in Texas became an Obamacare boogeyman
Erin Doherty, Axios
U.S. District Judge Reed O’Connor’s ruling last month — which the Justice Department said Wednesday it will appeal — has far-reaching implications for millions of Americans’ health plans.
Sanders plans to haul in insulin executives to testify in Senate
Rachel Cohrs and John Wilkerson, Stat News
Sen. Bernie Sanders plans to call the chief executives of the country’s largest insulin manufacturers to testify before his health committee, according to insulin maker Eli Lilly and two sources familiar with the plans. The move will keep the pressure on the companies over their prices despite the fact that they have said they plan to lower the list price of their older insulin products.
Suicide rises to 11th leading cause of death in the US in 2021, reversing two years of decline
Deidre McPhillips, CNN
Final data for the year shows that suicide was the 11th leading cause of death nationwide, with more than 14 deaths for every 100,000 people. The death rate has increased 32% over the past two decades, and the 4% jump between 2020 and 2021 was the sharpest annual increase in that timeframe.
Why xylazine, an “emerging threat,” doesn’t respond to Narcan
Kerry Breen, CBS News
Amy Werremeyer, the chair of the department of pharmacy practice at North Dakota State University, told CBS News that expecting naloxone to work on xylazine is akin to putting a star-shaped peg in a round hole.
As an Adderall Shortage Continues, Some Patients Put Lives on Hold
Alex Janin, The Wall Street Journal
Not being able to find certain stimulants can mean the difference between being able to work, sleep or perform daily tasks.
California Bill Would Mandate HPV Vaccine for Incoming College Students
Rachel Scheier, KFF Health News
A state lawmaker wants all incoming college students to get an HPV vaccine, as part of a push to drive up vaccination rates and prevent cervical cancer. At least four other states have enacted a similar mandate.
|
|
|
|
States confront medical debt that’s bankrupting millions
Jesse Bedayn, The Associated Press
These are three of an estimated 100 million Americans who have amassed nearly $200 billion in collective medical debt — almost the size of Greece’s economy — according to the Kaiser Family Foundation.
A majority of payers used outcomes-based contracting last year: survey
Paige Minemyer, Fierce Healthcare
The researchers surveyed 46 health plans based in the U.S. and found that 58% had at least one outcomes-based contract in place in the 2022 plan year. More than a third (35%) said they had at least 10 such contracts in place, according to the report.
CDC seeks new weapons against antimicrobial resistance
Frank Diamond, Fierce Healthcare
Michael Craig, who oversees cross-cutting antibiotic resistance activities for the Centers for Disease Control and Prevention, said discussions about the drug industry and antimicrobial resistance often focus on the development of new antibiotics, but that’s usually where the conversation ends because there’s no profit in it.
Medicare tests a solution to soaring hospice costs: Let private insurers run it
Leslie Walker and Dan Gorenstein, Tradeoffs
The experiment, which began in 2021, involved several thousand patients in its first year, but multiple experts told Tradeoffs they believe it is likely to eventually become national policy and reshape the hospice care available to roughly 30 million Americans.
As Montana’s Mental Health Crisis Care Crumbles, Politicians Promise Aid
Katheryn Houghton, KFF Health News
One of Montana’s largest mental health providers has ratcheted back services amid financial troubles, leaving a vacuum. State policymakers have promised more money to aid behavioral health care, but lasting change could be years out.
|
|
|
|
Abortion clinics reassure worried patients, set backup plans
Laura Ungar and Heather Hollingsworth, The Associated Press
Patients from near and far are “incredibly worried about whether or not they still have a valid appointment, whether they can obtain the care that they need. It’s heartbreaking,” said Mansanares, president and CEO of Planned Parenthood of the Rocky Mountains, which has clinics in Colorado, New Mexico and Nevada.
Doctors Seek Clarity From FDA as States Stockpile Abortion Pills
Celine Castronuovo, Bloomberg Law
Medical groups say they’re awaiting clearer guidance from the FDA and courts on the legality of prescribing state supplies of the abortion pill mifepristone, which could have its approval suspended this week.
Fitch Ratings: Workforce pressures easing for hospitals, ambulatory care, nursing homes
Dave Muoio, Fierce Healthcare
Recent months’ payroll and staffing data have largely brought good news for provider employers thanks to consistent monthly job additions, fewer open roles and, most recently, a slowdown in hourly earnings growth, according to a recent sector update from Fitch Ratings.
Nutrition, Exercise: Medical Schools Boost Teaching of Healthy Behaviors to Fight Chronic Disease
Laura Landro, The Wall Street Journal
Educators increasingly weave ‘lifestyle medicine’ principles into core curriculums for medical students.
Inaccurate Online Nursing Home Inspection Data Hit by Watchdog
Tony Pugh, Bloomberg Law
A government watchdog agency wants the Biden administration to tighten its public reporting of nursing home inspection results after finding that health and safety deficiencies at an estimated 10,300 facilities were not accurately listed on a federal consumer website.
|
|
|
|
Pharma, Biotech and Devices
|
|
Biopharmas take abortion pill fight to the courts, denouncing ‘chilling effect’ of judge’s ruling
Annalee Armstrong, Fierce Biotech
In the 4,542-word brief, the group of companies asked the U.S. Court of Appeals for the Fifth Circuit to grant the government’s request to stay a lower court’s ruling that blocked the decades-long approval of abortion drug mifepristone.
Cigna Is Giving Customers a Clearer View on Drug Pricing After Scrutiny
John Tozzi, Bloomberg
The insurance giant’s pharmacy-benefit management unit will market a “fully transparent” option charging a flat monthly fee for each member, with more visibility into manufacturers’ prices and discounts. The unit, Express Scripts, will also offer a plan that caps patients’ out-of-pocket costs from $5 to $45 per prescription, depending on the drug.
FDA staff leaned toward rejecting Sarepta gene therapy before top official intervened
Adam Feuerstein and Jason Mast, Stat News
Reviewers at the Food and Drug Administration were leaning toward rejecting a closely watched gene therapy for Duchenne muscular dystrophy made by Sarepta Therapeutics, prompting a top official to intervene earlier this year, according to three people with direct knowledge of the agency deliberations.
Novavax cut $50 million in costs, plans to slash more, CEO says
Patrick Wingrove, Reuters
Novavax, whose COVID-19 vaccine is its lone marketed product after 35 years in business, is relying on an updated COVID shot, cost cutting, and Phase 2 data on its COVID/influenza combination vaccine due in the coming weeks to stay afloat.
The Drug Company That Prospered Without Creating Any Drugs
Arthur Allen, KFF Health News
Horizon Therapeutics, which Amgen is acquiring for about $28 billion, grew large by snapping up cheap drugs from other companies, marketing them to perfection, and jacking up prices.
A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments
Matthew Herper, Stat News
The new findings, published in The Lancet Neurology, are the result of a 1,123-person study that has cost the Fox Foundation hundreds of millions of dollars since it began in 2010. Right now, alpha-synuclein can only be detected by taking a spinal tap, a difficult and uncomfortable procedure.
What’s pharma doing wrong to improve trial diversity? ‘Everything’
Karissa Waddick, PharmaVoice
Pharma’s missing the mark when it comes to recruiting Black patients, and Ricki Fairley, CEO of The Black Breast Cancer Alliance, reveals what’s needed.
Medical-Device Makers Gain Amid Return to Normalcy
David Wainer, The Wall Street Journal
Stryker, Edwards Lifesciences and Boston Scientific beat broader healthcare sector as procedure volumes rebound and costs stabilize.
|
|
|
|
New ONC rule aims to raise trust in clinical decision support algorithms
Rebecca Pifer, Healthcare Dive
The rule proposed Tuesday would give providers more information in their electronic health record system to assess clinical decision support algorithms and their results.
Microsoft expands cloud capabilities for payers, rolls out new AI services
Heather Landi, Fierce Healthcare
Microsoft, Google and Amazon Web Services (AWS) are pushing deeper into healthcare in a battle to provide cloud computing and data storage technology to hospitals, payers and other healthcare organizations.
Pear Therapeutics dreamt of huge revenues and ‘commercial scale.’ It never came close
Mario Aguilar, Stat News
In early April, Pear filed for bankruptcy and announced it would lay off almost all of its employees. In the wake of the filing, much has been made of the promise of the digital medicines that the company developed. Less has been said about how the company so misjudged its trajectory in believing that it was “poised for near-term commercial scale.”
Wireless pacemakers may work for children with slow heart rhythms — but first, doctors need child-sized catheters
Lizzy Lawrence, Stat News
Pacemakers, relied upon by many patients with irregular heart rhythms, are not built for children. Scrambling up trees, hanging from monkey bars, and even the simple act of growing make the device more likely to fail.
|
|
|
|
Opinions, Editorials and Perspectives
|
|
|
|
|
|