In The News

Provider Relief Fund: Phase 4 Payments

Beginning September 29, 2021, providers can now apply for Phase 4 payments from the Provider Relief Fund, with application submission through the Provider Relief Application and Attestation Portal. Providers must submit their completed application by the final deadline of October 26 at 11:59 p.m.

The application will require the following documentation:

  • Applicant TIN and TINs for any subsidiaries included in the applicant TINs IRS tax filing.
  • Internally generated financial statements that substantiate operating revenues and expenses from patient care in 2019 Q1, Q3, and Q4; 2020 Q3 and Q4; and 2021 Q1.
  • Federal income tax return, audited financial statements, or internally generated financial statements submitted in their entirety.

Most providers who have completed their PRF reporting for initial funding, should have this information gathered already.

Following is an announcement from HRSA regarding the portal.  Please note that the announcement contains information regarding another webinar on the funding (Oct. 5).

Dear Partner –

The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), has announced a new application cycle for $25.5 billion in COVID-19 provider funding. Applicants will be able to apply for both Provider Relief Fund (PRF) Phase 4 and American Rescue Plan (ARP) Rural payments during the application process. PRF Phase 4 is open to a broad range of providers with changes in operating revenues and expenses. ARP Rural is open to providers who serve rural patients covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP).

See a detailed list of eligible provider types here.

The application is open now and will close on October 26, 2021 at 11:59 p.m. ET. Providers who have previously created an account in the Provider Relief Fund Application and Attestation Portal and have not logged in for more than 90 days will need to first reset their password before starting a new application. In order to streamline the application process and minimize administrative burdens, providers will apply for both programs in a single application.

HHS recently hosted a briefing session to provide information about these upcoming funding opportunities – view the video here. HRSA will also host webinar sessions featuring guidance on how to navigate the application portal. Register now using the links below.

Real time technical assistance is available by calling the Provider Support Line at (866) 569-3522, for TTY dial 711. Hours of operation are 8 a.m. to 10 p.m. CT, Monday through Friday.

Marvin Figueroa, Director 

Office of Intergovernmental and External Affairs

U.S. Department of Health and Human Services

Washington, D.C.

 

USING YOUR BUDGET FOR CALCULATING LOST REVENUES FOR PRF REPORTING (From The Health Group) 

Three methods are available to healthcare providers for determining lost revenues eligible to be applied as a qualified use of Provider Relief Funds.  These are:

  • Option 1: Actual 2020 and 2021 revenues compared against 2019 revenues,
  • Option 2: Actual 2020 and 2021 revenues compared against 2020 budgeted revenues, or
  • Option 3: Alternate lost revenue computation.

We have received numerous inquiries regarding the use of budgeted revenues in the determination of lost revenues.  The following is provided by HRSA relating to the use of budgeted information:

“Lost revenues are calculated for each quarter during the period of availability, as a standalone calculation, with budgeted quarters serving as a baseline. For each calendar year of reporting, the applicable quarters where lost revenues are demonstrated are totaled to determine an annual lost revenues amount. The annual lost revenues for the years included in the period of availability are then added together. There is no offset.

Reporting Entities may use budgeted revenues if the budget(s) and associated documents covering the Period of Availability were established and approved prior to March 27, 2020.”

“When reporting use of Provider Relief Fund payments toward lost revenues attributable to coronavirus, Reporting Entities may use budgeted revenues if the budget(s) and associated documents covering calendar year 2020 were established and approved prior to March 27, 2020. To be considered an approved budget, the budget must have been ratified, certified, or adopted by the Reporting Entity’s financial executive, executive officer, or other responsible representative as of that date, and the Reporting Entity will be required to attest that the budget was established and approved prior to March 27, 2020. Documents related to the budget, including the approval, must be maintained in accordance with the Terms and Conditions.

https://www.hrsa.gov/sites/default/files/hrsa/provider-relief/prf-lost-revenues-guide.pdf specifically identifies the 2020 Budgeted Revenue as the basis for calculating budgeted revenues versus actual revenues for 2020 or 2021.

Many consultants are informing providers that they need a budget for 2021 for comparison to the actual revenues for the first two (2) quarters of 2021.  Other consultants are recommending the use of budgeted revenues for 2020 to actual revenues for 2020; however, they recommend using actual revenues for the first two (2) quarters of 2020 to be compared against actual revenues for the first two (2) quarters of 2021.

It is no wonder why many providers are confused.  HRSA has presented the following information which clearly indicates that a qualifying 2020 budget is not only used for comparison to actual 2020 revenues, but also that the first two (2) quarters of the 2020 budget are used for comparison against actual revenues for the first two (2) quarters of 2021.  As evidenced by the HRSA presentation, the first two (2) quarters of the 2020 budget are repeated for comparison against the 2021 actual revenues to determine lost revenues.

All providers are responsible for their submission and, accordingly, must select the process for identifying lost revenues; however, we believe the following as presented by HRSA is clear regarding the use of a qualifying 2020 budget (approved before March 27, 2020) solely as the basis against which actual revenues will be compared for both 2020 and the first two (2) quarters of 2021.  This approach makes sense as the 2020 budget would have been developed and accepted (before March 27, 2020) without considering any COVID-19 PHE impact, thus providing an appropriate comparison to actual revenues generated.

The entire HRSA presentation regarding “Period of Availability and Lost Revenues" is available here.  The information presented in the above slide has not been altered by any of the subsequent information released by HRSA.

 

COVID Vaccine For Kids Ages 5 To 11 Is Safe And Effective, Pfizer Says

Matt Rourke/AP

The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 showed promising results.

The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.

Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.

This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.

News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.

"Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," said Albert Bourla, the chairman and CEO for Pfizer.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," Bourla said in a statement.

Despite the strong results, it will be some time before the general public can see an official rollout of vaccines for children ages 5 to 11. Once analysis of the trial is completed, Pfizer and BioNTech will submit the results "in the near term" to the Food and Drug Administration for review and possible emergency use authorization.

A Vaccine For Children Is Not Likely To Be Approved Until The End Of Year

And even if the FDA grants that authorization, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR that parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for young children ages 5 to 11.

Trial results for children under 5 years of age could come later this year, the pharmaceutical companies said.

"Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for schoolkids to regulatory authorities around the world before the winter season begins," BioNTech CEO and co-founder Ugur Sahin said.

 
 

An FDA Panel Says Only High-Risk Americans And Those 65+ Should Get COVID Boosters

Hannah Beier/Bloomberg

In a surprising vote, a panel of advisers to the Food and Drug Administration on Friday recommended against approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older.

The 16-2 vote against broad use of the booster, which would be given about six months after completion of the two-dose immunization regimen, dealt a setback to Pfizer and complicates the FDA's approach to boosters.

After a brief intermission following the rejection, FDA officials returned to the meeting with a revised booster question. The panel then voted 18-0 in support of the agency authorizing a booster shot of the vaccine for people 65 and older or at high risk of severe COVID-19.

The FDA then polled the panel members for advice on other groups of people who might be considered for a booster. Though not an official vote, the panel members unanimously supported authorization of a Pfizer booster dose for health care workers or others at high risk of occupational coronavirus exposure.

The agency typically follows the advice of its advisory committees, though it isn't required to. The Biden administration said in August that it planned to make booster shots available during the week of Sept. 20. That announcement was controversial because it came before the FDA had weighed Pfizer's application and before the Centers for Disease Control and Prevention's own panel of experts on immunization practices could consider the need for boosters.

The rise of the highly infectious delta variant of the SARS-CoV-2 coronavirus and some evidence that the Pfizer vaccine's protection against infections wanes with time are two of the factors that were cited in support of a booster.

But presentations Friday generally showed that the vaccine is still effective in protecting immunized people against severe illness, hospitalization and death in the United States.

Separately, however, an analysis published Friday in the CDC's "Morbidity and Mortality Weekly Report" found that the Pfizer vaccine's protection against COVID-19 hospitalization dropped from 91% during the first 120 days after vaccination to 77% in the days after that.

Over the course of the meeting, speakers from the FDA, Pfizer, the CDC, Israel and the U.K. presented data on the state of the coronavirus pandemic, experience with the Pfizer vaccine and lab tests.

The most direct support for the Pfizer booster came from laboratory work and a clinical study done by Pfizer that involved a little over 300 people.

"The difficulty for the committee is that you're making incredibly important policy decisions very rapidly in asituation of uncertainty," said Jonathan Sterne, a statistician from the University of Bristol who made a presentation to the panel.

 

Misdirected antibodies linked to severe COVID-19

National Institutes of Health (NIH) / By Sharon Reynolds

The severity of COVID-19 can differ drastically between individuals. Some people never know they’ve been infected, while others may end up needing intensive care or dying from the disease.

Several factors have been associated with severe COVID-19, including preexisting health conditions like obesity, diabetes, and high blood pressure. Men are more likely to die of the disease than women. And the risk of dying from COVID-19 increases with age.

Researchers around the world have been looking for other risk factors for severe or fatal infection with SARS-CoV-2, the virus that causes COVID-19. An international project called the COVID Human Genetic Effort has been searching for genetic and molecular differences that may increase the risk of severe COVID-19. The project is co-directed by Dr. Helen Su from NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Dr. Jean-Laurent Casanova from Rockefeller University.

Two recent studies from the project, led by Casanova, found that some severe cases of COVID-19 could be linked to problems with immune-system proteins called type I interferons (IFNs). These IFNs are needed to fight off viral infections. In rare cases, genetic conditions blocked the production of these proteins. But more commonly, antibodies that mistakenly targeted the IFNs were found in the blood of people with severe or fatal COVID-19.

To better understand how common these autoantibodies are, Casanova and his colleagues screened for them in blood samples taken from more than 3,500 people with severe or fatal COVID-19 and more than 34,000 uninfected volunteers from 38 different countries. The new study was funded in part by several NIH components, primarily NIAID. Results were published on August 19, 2021, in Science Immunology.

The team found that 20% of people hospitalized with severe COVID-19 had high or intermediate levels of autoantibodies to type I IFNs. Autoantibodies were also found in at least 18% of people who died from the disease. In contrast, people with no or mild symptoms had very low levels of these autoantibodies. The researchers estimate that the autoantibodies may account for about 20% of total fatal COVID-19 cases.

The risk of having such autoantibodies increased with age. For example, while fewer than 10% of people under the age of 40 with severe COVID-19 had active levels of these autoantibodies, more than 21% of those over the age of 80 had them.

The researchers also found evidence of autoantibody production in uninfected volunteers. They were found in less than 1% of people between 18 and 69 years; in 2.3% of those between 70 and 79 years; and in 6.3% of those 80 years and older. This suggests that type I IFN autoantibodies existed before infection and become more common past age 70.

In a related paper published in the same issue of Science Immunology, the researchers identified another rare genetic defect that occurs only in men and results in disruption of IFN production. They estimated that this genetic risk factor accounts for at least 1% of cases of life-threatening COVID-19 in men under the age of 60.

“We can neatly explain much of severe COVID-19 as a net defect in type I IFN,” Casanova says. “To an extent never seen for any other acute infectious disease, these… studies collectively provide a molecular and immunological explanation for about 20% of critical cases.”

Autoantibodies against IFNs—at even very low levels—can be screened for in the clinic. Testing for these autoantibodies could help identify uninfected people who need aggressive preventive measures or infected people who need early aggressive treatment.

 
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