In The News

Pfizer Says Its RSV Shot Is Protective Through a Second Year

Medscape | By Michael Erman

NEW YORK (Reuters) - Pfizer on Thursday said a single dose of its new respiratory syncytial virus (RSV) vaccine Abrysvo maintained its ability to protect against the illness through a second year of respiratory disease season.

The company said in a press release that the vaccine's efficacy against RSV-associated lower respiratory tract disease with three or more symptoms was 77.8% through season two, compared with efficacy of 88.9% after the first RSV season, which led to the shot's U.S. approval.

The data is from a late-stage trial of more than 37,000 participants being conducted in both the Northern and Southern hemispheres.

Cumulative efficacy over both seasons after around 16.4 months of disease surveillance was 81.5%, Pfizer said.

The data is similar to the efficacy of GSK's rival RSV shot Arexvy over two seasons, which was released in June.

Both companies launched their RSV vaccines in the U.S. last year. Pfizer Chief Executive Albert Bourla has called his company's launch a disappointment, after taking only around 35% market share in the first season.

Pfizer said no new adverse events cropped up through the second RSV season beyond those reported in the clinical trial during the first season.

The company plans to submit the new data to regulatory authorities and publish these findings in a scientific journal.

 

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Hill Leaders Announce Deal to Unlock Final Spending Bills

Roll Call | By Aidan Quigley

Congressional leaders reached an agreement on final fiscal 2024 appropriations bills Wednesday that will pave the way for lawmakers to wrap up the process in two packages in the coming days and weeks.
 
Funding for agencies covered by the Agriculture, Energy-Water, Military Construction-VA and Transportation-HUD bills would be extended from March 1 through March 8 in a stopgap bill. Those agencies’ full-year bills would then join the Interior-Environment and Commerce-Justice-Science bills in the first tranche to be voted on [this] week.
 
Appropriators [were] aiming to release text for the first batch of bills by [last Sunday] in order for the House to be able to turn around and vote Wednesday, before Thursday gets swallowed up by President Joe Biden’s State of the Union address. In theory, that would give the Senate time to get the first package to Biden’s desk before the impacts of a partial shutdown on those agencies subject to the new March 8 deadline are felt.
 
Stopgap funding for the remaining six bills, which had been set to lapse after March 8, would last through March 22, giving lawmakers enough time to finish turning the deal into legislative text and getting the bills through both chambers. That package would consist of the Defense, Labor-HHS-Education, Homeland Security, Financial Services, State-Foreign Operations and Legislative Branch measures.
 
Leaders on Wednesday released the two-tiered stopgap extension bill, which the House could vote as soon as Thursday under suspension of the rules. The Senate is expected to follow by the end of the week. However, any one senator could always delay passage, which would result in a short lapse. But the effects of one wouldn’t be felt until Monday, when federal workers would return to work.
 
The stopgap bill will give the Appropriations committees time “to execute on this deal in principle, including drafting, preparing report language, scoring and other technical matters, and to allow members 72 hours to review,” a joint statement from congressional and appropriations leadership read…
 
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Health Care Quality Took a Big Hit During COVID, Medicare Report Finds

Axios | By Maya Goldman
 
Progress on many key health care quality measures was reversed during the first two years of the pandemic, according to a new comprehensive federal review. 
 
Why it matters: The report identified a "significant worsening" of patient safety measures and "persistent" health equity gaps for historically disadvantaged patients as COVID-19 overwhelmed the health care system. 
 
Context: The federal government asks providers to report on a wide set of several hundred measures meant to assess health care quality. 

  • Before the pandemic, from 2016 to 2019, providers' performance on more than half of quality metrics improved, the Centers for Medicare and Medicaid Services said. 
  • CMS relaxed reporting requirements when the pandemic hit, but the agency said it continued to collect enough data to compare performance with long-term trends. 


Zoom in: Performance on 38% of measures came in worse than expected in 2020, and 47% worse in 2021, CMS said. 

  • About half of safety measures came in worse than expected in those two years. 
  • In the starkest example, a measure of central line-associated bloodstream infections was 94% worse than expected in 2021.

 
Quality scores decreased more significantly for minority populations on some measures. 

  • For instance, osteoporosis management for Black Medicare Advantage enrollees was 22.4 percentage points worse in 2021, while it fell 14.4 percentage points for white enrollees. 

 
The bottom line: CMS said the data and feedback from focus groups show the need to develop measures that "address bias in care delivery and deficits in cultural competency, unmet health-related social needs, access, and health literacy."

 

Untangling The History, Causes Behind The Precipitous Home Health Aide Utilization Drop

Home Health Care News | By Patrick Filbin
 
In the last home health proposed rule from the Centers for Medicare & Medicaid Services (CMS), the federal agency in charge of reimbursement rates sent out a request for information on home health aide utilization.
 
Specifically, the agency wondered why Medicare-covered home health aide visits and utilization had fallen off a cliff over the last few decades.
 
According to the Center for Medicare Advocacy, home health aide visits declined by 90% from 1998 to 2019.
 
Many people who work in and around home health were surprised by the CMS request, believing the agency itself was one of the main culprits. “When we saw that go into the proposed rule, we laughed out loud,” National Association for Home Care & Hospice (NAHC) President Bill Dombi told Home Health Care News.
 
Home health aide history
 
In 1987, Dombi took part in a class action lawsuit on behalf of NAHC and home care patients against the Medicare program. There were a whole host of issues within the lawsuit, Dombi recalled, but one of them had to do with the accessibility to home health aide services. The lawsuit was successful, and created a standard that ultimately found itself into the statute itself.
 
“Congress modified the law to pretty much codify the outcome of the lawsuit,” Dombi said. “It set a standard that an individual could qualify for 28 to 35 hours a week of home health aide services within the definition of part-time or intermittent care — which had been the part of the statute that I litigated around.”
 
At that point in time, home health aides services were the primary discipline of care that people were receiving for services — more than even nursing care.
 
Then, two things happened. In the Balanced Budget Act of 1997, Congress eliminated blood draws from the list of benefits that could qualify a person for the home health aide benefit. That dilution of the benefit was compounded by a major change in the reimbursement model for home health services — the Interim Payment System.
 
This system aimed to change the way Medicare paid for home health services. Instead of paying providers based on the costs they incurred, Medicare transitioned to a prospective payment system.
 
Under the IPS, Medicare made fixed payments to home health agencies based on the patient’s condition and the services needed rather than reimbursing them for the actual costs of care. This change was intended to control costs and improve efficiency in the Medicare home health benefit.
 
“It devastated home health agencies and home health services,” Dombi said. “Forty percent of home health agencies shut down within an 18-month period of time. The volume of patients served in the Medicare program went from 3.5 million to 2.1 million in that same 18-month period of time.”

Prior to the IPS, agencies received more reimbursement for the more services they provided. With IPS, agencies had a cap on what would be payable.
 
“That really chilled the providers’ willingness to take on patients that had high levels of home health aide services,” Dombi said. “Because it raised the level of payment, but you then hit against the cap. And when you hit the cap, you didn’t get the payment.”
 
When the Prospective Payment System (PPS) system was implemented in 2000, home health aide services were already dwindling.
 
The episode of payment for home health services is around $2,000 for 30 days worth of care. Adding 30 days of home health aide services — at an average of about four hours a day — would add between $3,000 to $4,000 to the cost of care, Dombi estimated.
 
“You can’t expect a home health agency to get paid $2,000 to deliver $5,000 to $6,000 worth of care,” he said. “As an existing care provider, they would last a nanosecond if they started doing that. So at the moment, it’s all reimbursement related.”
 
That brings the timeline to 2023 when CMS essentially asked, “Why are home health aide services so difficult to get for patients?”…

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