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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Home Health Leaders Call for Bill Abolishing Medicare Payment Cut 

McKnights Home Care / By Diane Eastabrook

Home health leaders descended on Capitol Hill Tuesday to protest the Centers for Medicare & Medicaid Services’ proposed 7.69% Medicare payment cut to home health firms. The Partnership for Quality Home Healthcare and the National Association for Home Care & Hospice called on Congress to enact legislation that would prevent the cuts.

“We urge Congress to step in and advance legislation to prevent these severe cuts from being implemented in 2023,” Joanne Cunningham, CEO of the Partnership, said in a statement. “Home health is widely preferred by patients and their families. At a time when home-based care is needed for the health and safety of seniors, we will work with our champions in Congress to ensure that the delivery of quality patient care and the stability of our community are protected.”

CMS last month announced the proposed rule, which would cost providers up to $1.33 billion in 2023 and up to $2 billion in 2024 in clawback payments for home health services delivered during the COVID-19 pandemic to seniors and people with disabilities. 

Home health advocates say the proposed cut could financially decimate providers at a time when inflation is driving up the cost for everything from worker wages to energy. Just days after CMS announced the cut, NAHC President and CEO William Dombi threatened possible legal action if the cuts went into effect. 

The public has until mid-August to file formal comments on the proposal to CMS. The agency is expected to make a decision on the rule in the fall.

Resources


CY 2023 HH PPS Proposed Rule - Public Comment Period Now Open

The CY 2023 HH PPS proposed rule is now available for viewing and download on the Federal Register. The public comment period is open until Tuesday, August 16, 2022 at 11:59 PM ET. Instructions on how to submit comments are available on the Federal Register

 

Submit Your Nomination for the 2022 Outstanding PT & PTA of the Year Awards!

Please submit your nomination below for the APTA Colorado Chapter Outstanding PT and PTA of the Year Awards! The Outstanding PT and PTA of the year is a chapter member that demonstrates Excellence in an area of practice (clinical, administration, research, and education) and has made significant contributions to the profession, the community, and the chapter. All nominees must be current members of the APTA Colorado Chapter. Nominations must be submitted by Thursday, July 21, 2022If you have any questions, please reach out to us at [email protected]

Click here to submit your nomination!

 

MEDPAC Releases June Report to Congress

The Health Group 

The Medicare Payment Advisory Commission (“MedPAC”) has released the June 2022 Report to Congress, Medicare and the Health Care Delivery System.  The Report includes seven (7) chapters devoted to:

  • Ways to streamline and harmonize Medicare’s portfolio of alternative payment models,
  • Vulnerable Medicare beneficiaries’ access to care,
  • A framework for identifying safety-net providers,
  • Addressing the high prices of drugs covered by Medicare Part B,
  • Improving the accuracy of Medicare Advantage payments,
  • Aligning fee-for-service payment rates across ambulatory settings, and
  • Segmentation in the stand-alone Part D prescription drug plan market.

The entire Report is available here

 

Health Care Fraud and Abuse Control Program FY 2021 Report Issued

From the Health Group

The Department of Health and Human Services and the Department of Justice have released the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2021

During FY 2021, the federal government won or negotiated more than $5 billion in health care fraud judgments and settlements.  The Report provides highlights of significant criminal and civil investigations by type including:

  • Ambulance transportation services
  • Clinics
  • Diagnostic testing
  • Drug companies
  • Durable medical equipment
  • Electronic health records
  • Genetic testing
  • Home health providers
  • Hospice care
  • Hospitals and health systems
  • Laboratory testing
  • Managed care
  • Medical devices
  • Nursing homes and facilities
  • Pharmacies
  • Physical therapy
  • Physicians and other practitioners
  • Prescription drugs and opioids
  • Psychiatric and psychological testing and services
  • Substance use treatment centers

The Report provides an all-inclusive look into the current and potential activities relating to the identification and pursuit of fraudulent and abusive activities, including Medicare provider screening.  All providers should be continuously aware of areas of focus as described in the Report.  The entire Report is available at FY 2021 HCFAC Report (hhs.gov).

 
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