Morning Consult Health Presented by the Partnership for Quality Home Healthcare: Senate HELP Leaders Reach Deal on FDA User Fee Bill




 


Health

Essential health care industry news & intel to start your day.
September 23, 2022
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Today’s Top News

  • Senate Health, Education, Labor and Pensions Committee ranking member Richard Burr (R-N.C.) reached an agreement with Sen. Patty Murray (D-Wash.), the committee chair, on a five-year reauthorization of the Food and Drug Administration’s user fee programs, a “practically clean” bill, per Burr, which includes some policy riders that he did not specify. (Roll Call) Two sources familiar with the discussions said Senate Minority Leader Mitch McConnell (R-Ky.) will push for a totally clean five-year user fee bill, blocking the riders from being attached to the short-term government funding bill, which Congress is planning to consider next week. (Politico Pro)
  • Sen. Roger Marshall (R-Kan.) has moved to force a vote in the chamber on ending the COVID-19 national emergency declaration, citing President Joe Biden’s comments that “the pandemic is over” while the administration pushes for billions in fresh funding. (The Wall Street Journal) The Biden administration, meanwhile, is scaling back its target for COVID-19 vaccine donations as global demand for the shots sags, amending its deal with Pfizer Inc. to secure 600 million vaccine doses by the end of 2022 instead of 1 billion. (Bloomberg)
  • Maria Van Kerkhove, the World Health Organization’s COVID-19 technical lead, said cutbacks to testing and surveillance of the virus by governments around the world have made it increasingly challenging to track new variants. WHO Director-General Tedros Adhanom Ghebreyesus said that while the pandemic’s “end is in sight,” there remains a “risk of more dangerous variants emerging.” (CNBC)
  • In a 56-40 vote, the Senate confirmed Arati Prabhakar as director of the White House Office of Science and Technology Policy, making her the first woman, person of color and immigrant to hold the position. Prabhakar, who previously led the Defense Advanced Research Projects Agency, will also assume the Cabinet-level position of Biden’s science adviser, stepping in for former National Institutes of Health Director Francis Collins, who served in the role on an interim basis. (Bloomberg Law)

Worth watching today (all times local): 

  • 9 a.m. FDA meeting of the Oncologic Drugs Advisory Committee.
  • 1 p.m. Harvard T.H. Chan School of Public Health event: “Long COVID: The search for answers,” featuring Assistant Secretary for Health Rachel Levine.
 

Chart Review



 
 

What Else You Need to Know

Coronavirus
 

Pfizer Will Begin Distribution Of 6 Million Paxlovid Treatments To Low-And-Middle Income Countries

Arianna Johnson, Forbes 

Pfizer has begun providing 132 low- and-middle-income, Global Fund-eligible countries with six million Paxlovid treatment courses. Initially announced in May, the shipment is part of Global Fund’s Covid-19 Response Mechanism, the independent financing company’s main avenue for providing Covid tests, treatment and equipment to these countries.

 

COVID raises risk of long-term brain injury, large U.S. study finds 

Julie Steenhuysen, Reuters 

People who had COVID-19 are at higher risk for a host of brain injuries a year later compared with people who were never infected by the coronavirus, a finding that could affect millions of Americans, U.S. researchers reported on Thursday.

 

Covid 19 Infection Linked to More Type 1 Diabetes in Kids and Teens 

Dong Lyu, Bloomberg 

Covid-19 in children and teens appeared to raise the risk of developing diabetes in two studies that didn’t settle the debate about whether the coronavirus can trigger the chronic condition.

 

4.4M Americans Roll up Sleeves for Omicron-Targeted Boosters

Carla K. Johnson, The Associated Press 

U.S. health officials say 4.4 million Americans have rolled up their sleeves for the updated COVID-19 booster shot. The Centers for Disease Control and Prevention posted the count Thursday as public health experts bemoaned President Joe Biden’s recent remark that “the pandemic is over.”

 

Moderna Covid-19 Booster Shortage Leads to Fewer Appointments at Pharmacies 

Peter Loftus, The Wall Street Journal

Some U.S. pharmacies and other vaccine providers are offering the new Covid-19 booster shot only from Pfizer Inc. and BioNTech SE, after a manufacturing-quality problem at a contract manufacturer caused a shortage of Moderna Inc.’s new booster shot.

 

Why COVID Is Still Worse Than Flu 

Sarah Zhang, The Atlantic 

When is the pandemic “over”? In the early days of 2020, we envisioned it ending with the novel coronavirus going away entirely. When this became impossible, we hoped instead for elimination: If enough people got vaccinated, herd immunity might largely stop the virus from spreading. When this too became impossible, we accepted that the virus would still circulate but imagined that it could become, optimistically, like one of the four coronaviruses that cause common colds or, pessimistically, like something more severe, akin to the flu.

 

Why Omicron Might Stick Around  

Carl Zimmer, The New York Times 

Where is Pi? Last year, the World Health Organization began assigning Greek letters to worrying new variants of the coronavirus. The organization started with Alpha and swiftly worked its way through the Greek alphabet in the months that followed. When Omicron arrived in November, it was the 13th named variant in less than a year.

 

Some Who Rushed to Covid-19 Vaccine Hold Off on Boosters 

Jared S. Hopkins, The Wall Street Journal

Health authorities encouraging retooled Covid-19 boosters are facing resistance from an unlikely corner: people who had embraced vaccines earlier in the pandemic.

 

New analysis supports Paxlovid use

Tina Reed, Axios 

Here’s one more data point to consider in the back-and-forth about Pfizer’s antiviral pill Paxlovid: A new analysis found it can meaningfully reduce COVID hospitalizations and deaths, even in those younger than 65.

 

New global initiative aims to hasten long COVID research

Anastassia Gliadkovskaya, Fierce Healthcare 

The Long Covid Research Initiative (LCRI), part of the nonprofit PolyBio Research Foundation, is run by a team of about a dozen volunteers and thus far has amassed a roster of two dozen researchers and clinicians. While its efforts have been ongoing for the better part of the year, a formal announcement about the LCRI was made in early September. 

 
General
 

Biden to announce $1.5 billion to fight U.S. opioid crisis 

Ahmed Aboulenein, Reuters 

U.S. President Joe Biden will announce on Friday nearly $1.5 billion to fund access to medications for opioid overdoses, sanctions against traffickers, and increased funding for law enforcement, the White House said.

 

DOJ: States can’t penalize VA doctors and nurses for legal abortions

Jacob Knutson, Axios 

States cannot impose civil or criminal penalties on Department of Veterans Affairs doctors and nurses who provide abortion services that are allowed by federal law, a Department of Justice task force said in a new memo released Thursday.

 

White House: GOP abortion ban would mean a nationwide crisis

Colleen Long, The Associated Press

The White House and the American College of Obstetricians and Gynecologists say a Republican-led proposal to ban abortion nationwide after 15 weeks would endanger the health of women and have severe consequences for physicians.

 

COVID, Roe v Wade decision threaten cancer progress, scientists say

Eileen Drage O’Reilly, Axios 

The great strides in cancer survivability seen in recent decades could be undercut by fallout from the pandemic, the overturning of Roe v. Wade, and continued disparities in health care access, scientists warn.

 

VA performs its first abortion weeks after saying it would in certain cases

Courtney Kube and Minyvonne Burke, NBC News 

The VA medical system performed its first abortion, weeks after an interim final rule was announced that allowed it to provide the service in the case of incest, rape, or when the life of the mother was in jeopardy.

 

RAND: Drug treatment admissions fell 24% in 2020

Robert King, Fierce Healthcare 

Drug treatment program admissions declined by 24% in 2020 due to the pandemic as overdose deaths have surged, a new study found.

 

Judge temporarily blocks Indiana’s near-total abortion ban

Oriana Gonzalez, Axios 

A judge in Indiana on Thursday temporarily blocked a near-total abortion ban in the state that had been in effect for a week.

 
Payers
 

Humana, CVS Circle Cano Health as Potential Buyers 

Laura Cooper and Dana Cimilluca, The Wall Street Journal

Humana Inc. and other possible buyers are circling Cano Health Inc., according to people familiar with the situation, as healthcare heavyweights scramble to snap up primary-care providers.

 

Providers urge CMS to change policy for split visit payment 

Maya Goldman, Modern Healthcare 

Providers want the Centers for Medicare and Medicaid Services to change a forthcoming policy on reimbursement for hospital visits when both a physicians and non-physician providers see patients. 

 

Medicaid coverage for some children might end soon, experts warn

Frank Diamond, Fierce Healthcare 

The number of children without healthcare coverage could increase come next year as a congressional emergency provision to deal with the COVID-19 pandemic ends.

 

Shakeup with Optum’s health data licensing sparks outcry among scientists

Casey Ross, Stat News

A move by Optum to change longstanding practices for licensing data to academic institutions has sparked an outcry among researchers, who argue the move will make accessing data so costly and difficult that universities will scale back their research programs.

 
Providers
 

Moody’s: Envision Healthcare at risk for bankruptcy, loan defaults 

Caroline Hudson, Modern Healthcare 

Moody’s Investors Service added to Envision Healthcare’s financial woes by downgrading the outpatient surgery and physician staffing company’s debt on Wednesday.

 

Buy and Bust: After Platinum Health Took Control of Noble Sites, All Hospital Workers Were Fired 

Sarah Jane Tribble, Kaiser Health News 

Noble Health, a three-year-old private equity-backed startup, had acquired Audrain and nearby Callaway Community Hospital during the pandemic. In March, it suspended all hospital services and later furloughed 181 employees, state records show. 

 

Surprise billing lawsuit from Texas doctors 

Maya Goldman, Modern Healthcare 

The Texas Medical Association filed its second lawsuit against the federal government’s surprise billing arbitration process Thursday. 

 
Pharma, Biotech and Devices
 

White House casts drug pricing law as way to extend cancer patients’ lives 

Rachel Cohrs, Stat News

A new analysis by the Council of Economic Advisers focused on the new law capping Medicare patients’ out-of-pocket costs for pharmacy drugs at $2,000 per year, starting in 2025. Over 449,000 current Medicare enrollees with a prior cancer diagnosis would save an average of nearly $1,600 per year on prescription drugs because of the out-of-pocket cap. Right now, there’s no limit on patients’ out-of-pocket costs.

 

House GOP eyes repeal of Dems’ drug pricing law 

Peter Sullivan and Victoria Knight, Axios

Some key House Republicans are calling for the repeal of Democrats’ newly-passed drug pricing measure if the GOP flips control of one or both chambers of Congress next year.

 

Opioid-Reversal Drug Access to Ease Under Relaxed FDA Rules

Celine Castronuovo, Bloomberg Law 

Harm reduction programs distributing the opioid-reversal drug naloxone are exempt from certain federal product tracing requirements in an effort to better expand supply, the FDA said Thursday.

 

Antibiotic Prescribing Gets Fresh Look After Covid-Era Setbacks 

Celine Castronuovo, Bloomberg Law

The CDC is devoting funding to dozens of local health departments for programs to stop improper antibiotic prescribing following the rise in deadly bacterial and fungal infections during the Covid-19 pandemic.

 

NIH launches next stage of its ‘human genome project’ for the brain 

Jonathan Wosen, Stat News

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations.

 

FDA Clashes With Swedish Biotech Seeking to Resume Cancer Drug Sale

Joseph Walker, The Wall Street Journal

The Food and Drug Administration is in a standoff with the Swedish biotech Oncopeptides AB over whether the company should be able to sell its anticancer drug, after a clinical trial indicated the therapy might harm patients.

 

Alzheimer’s drug trial brings pivotal test of maligned brain plaque theory 

Jamie Smyth, Financial Times 

Study of Eisai treatment will be one of last chances to prove amyloid hypothesis, say experts.

 
Health Technology
 

Health apps share your concerns with advertisers. HIPAA can’t stop it. 

Tatum Hunter and Jeremy B. Merrill, The Washington Post 

Digital health care has its advantages. Privacy isn’t one of them. In a nation with millions of uninsured families and a shortage of health professionals, many of us turn to health-care apps and websites for accessible information or even potential treatment. But when you fire up a symptom-checker or digital therapy app, you might be unknowingly sharing your concerns with more than just the app maker.

 

Oracle plans to ‘rewrite’ VA’s Cerner EHR system in 2023

Heather Landi, Fierce Healthcare 

Tech giant Oracle promised lawmakers this week that it would revamp the beleaguered Cerner computer system being deployed at Veterans Affairs hospitals.

 

New details on Apple Watch study emphasize Medicaid enrollment

Mario Aguilar, Stat News 

Newly published details about a high-profile Apple Watch study call it “a priority” to recruit Medicaid patients — a population not usually considered the target for Apple’s pricey products.

 
Opinions, Editorials and Perspectives
 

Market share isn’t the only metric for biosimilars’ success

Jeff Baldetti, Stat News

Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures.

 







Morning Consult