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CMS Administrator Chiquita Brooks-LaSure Reemphasizes Home- and Community-Based Services Focus

Home Health Care News | By Joyce Famakinwa
 
On Tuesday, the U.S. Centers for Medicare & Medicaid Services (CMS) took the time to map out the federal agency’s strategic plans and key initiatives moving forward.
 
During the national stakeholder call, CMS Administrator Chiquita Brooks-LaSure, CMS Chief Operating Officer Jon Blum and Deputy Administrator and Director of Center for Medicaid and CHIP Services Dan Tsai, among others, discussed Medicare program compliance, payment innovation and protecting the Medicare program for years to come.
 
“We really have tried, over the Biden-Harris Administration, to be really clear in saying what our objectives are,” Brooks-LaSure said. “It’s been a little over a year since we unveiled the six pillars, which really were meant to help guide our work.”

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FDA Authorizes Novavax Covid Vaccine, in Hopes the Traditional Shot Will Convince Holdouts

StatNews | By Matthew Herper

The Food and Drug Administration on Wednesday authorized the Covid-19 vaccine developed by Novavax, a small Maryland biotech firm, for people 18 and over, voicing hope that the availability of a more traditional vaccine might help convince those skeptical of the Covid shots using new mRNA technology to get inoculated.

As with other Covid vaccines, the Novavax shot will be free to consumers, because the U.S. government will purchase the doses. But before the vaccine will be widely available, it must also be recommended by the director of the Centers for Disease Control and Prevention. That recommendation will likely follow a July 19 meeting of an expert committee convened by the CDC.

“Authorizing an additional Covid-19 vaccine expands the available vaccine options for the prevention of Covid-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf in a prepared statement. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The U.S. has received 3.2 million doses of the vaccine that are ready to be shipped to states once the vaccine is authorized and recommended by the CDC.

“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” said Stanley C. Erck, Novavax’s CEO. “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”

Unlike the vaccines from Pfizer/BioNTech and Moderna, the Novavax vaccine has had a bumpy path to the market. Novavax received $1.6 billion in support from the U.S. government’s Operation Warp Speed project in July 2020. At the time, the hope was that the company might begin making a vaccine by the beginning of 2021. But while the Moderna and Pfizer/BioNTech shots released data in November of 2020, results were not available for the Novavax vaccine until June of 2021.

There were also questions about the ability to produce the vaccine in large amounts. The original deal between Novavax and Operation Warp Speed would entitle the U.S. to 100 million doses of the vaccine. In the press release announcing the vaccine’s emergency use authorization, FDA officials emphasized that the vaccine had not only met the FDA’s bar for safety and efficacy but also “assessment of the manufacturing processes and information.”

In June, a panel of FDA advisers voted 21 to 0, with one abstention, that the Novavax vaccine’s benefits outweigh its risks.

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Report Paints Rosy Picture for Home Healthcare

McKnight’s Home Care | By Diane Eastbrook

Despite inflationary and staffing headwinds, the healthcare industry — and home care in particular — is poised for significant growth, according to a report released Tuesday by business consulting firm McKinsey & Company. 
 
The report said care-delivery services outside of the hospital are the fastest-growing businesses for providers, given the shift away from non-acute care settings. Shubham Singhal, a McKinsey senior partner and co-author of the report, told McKnight’s Home Care Daily Pulse that innovators will bring multiple services into the home including, infusion, dialysis, primary care and hospital-at-home.
 
“Over the next few years, we estimate that Medicare beneficiaries could see three to four times more care in their homes if we continue to bring known capabilities to scale,” Singhal said. “Based on our projections, these efforts could translate into a shift of up to $265 billion of incremental Medicare spending from traditional facilities into the home.”  

In-home healthcare for everything from hospital-at-home to dialysis to primary care has been gradually gaining ground since the beginning of the COVID-19 pandemic. Currently, more than 200 hospitals and healthcare systems are offering hospital-level care to patients in their homes and the Center for Medicare and Medicaid Services’ End Stage Renal Disease Treatment Choices Model aims to move more dialysis into homes and save Medicare $23 million over five years. 
 
Singhal said growth in technology, especially broadband access, will determine how quickly in-home healthcare will grow. He pointed out that an estimated 20 million Americans in mostly rural areas still lack reliable broadband access and in-home these services must also find ways to “knit together” the use of virtual care and in-person care. 
 
The report also found that the COVID-19 pandemic led to a rise in deteriorating mental health and an increase in chronic diseases as patients skipped care. It estimated the cost of care grew by $10 billion last year and will increase another $7 billion by 2025.
 
Singhal said there is no single solution to mitigating the increase in chronic conditions, but said focusing on behavioral health, disease prevention and social determinants of health should be part of the focus.
 
“Our analyses have shown that we can reduce the burden of chronic disease in the U.S. through known interventions, but it would require a dedicated and focused effort over time,” he said.

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