In The News

FDA Approves First COVID-19 Vaccine

Approval Signifies Key Achievement for Public Health 

For Immediate Release:

August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. 

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

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The 2022 Hospice Final Rule: Coping with change in uncertain times (Free Wellsky Webinar)

July 29, at 12:00 MT

The webinar is designed to help participants calculate hospice labor shares and payment changes, and understand specifics of the Hospice Election. Further details and registration are online through the following LINK 

 

 
 

NHPCO Episode 116 (Hospice FY2022 Final Rule)

In this month's podcast, JR talks with NHPCO's Judi Lund Person and Jennifer Kennedy about the FY22 Hospice Wage Index Final Rule. Along with basic information about the wage index values and rates, Judi and Jennifer take a deeper dive into how the final rule will affect providers - from regulatory areas of interest for CMS to changes in public reporting and data. Listen now.

 

Home Health Value-Based Purchasing (HHVBP) Model

Fourth Annual Evaluation Report Key Takeaways:

The first four years of the implementation of HHVBP (2016-2019) have resulted in cumulative Medicare savings of $604.8 million, a 1.3% decline relative to the 41 non-HHVBP states, as well as improvements in quality. These impacts were observed during 2019, the second year for quality based payment adjustments, as well as the initial three years of the model. We will continue to evaluate the impact of HHVBP on quality and Medicare spending as the maximum payment adjustments become larger each year.

The Two Page Overview:

The Report (includes an Executive Summary):

Additional Supporting Materials:

 

Program – OASIS Interim Guidance [Recorded] Webinar (Advanced Webinar)

The Centers for Medicare & Medicaid Services (CMS) invites Home Health providers to listen to the [recorded] Home Health Quality Reports Program’s OASIS Interim Guidance Webinar. In an effort to provide an overview of important OASIS data collection clarifications, CMS has developed this webinar to highlight some of the more significant OASIS guidance refinements that have been made available in recent Quarterly Q&A releases.

Please note that this webinar is NOT intended to provide basic or comprehensive OASIS training. The training materials can be accessed via the Home Health Quality Reporting Program Training page.

 
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