In The News

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 a situation of uncertainty," said Jonathan Sterne, a statistician from the University of Bristol who made a presentation to the panel.

 

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$25.5 Billion in New COVID-19 Provider Funding Available

The U.S. Department of Health and Human Services (HHS), through the (HRSA) is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.

Providers, defined as any provider or supplier of health care, services, and support in a medical setting, at home, or in the community, will apply for both programs in a single application. HRSA will use existing Medicaid, CHIP and Medicare claims data in calculating payments. The application portal will open on September 29, 2021.

PRF Phase 4

75% of the Phase 4 payments will be based on lost revenues and expenditures between July 1, 2020, and March 31, 2021. The remaining 25% of payments will be utilized for bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients.

Medium and small providers will receive a base payment plus a supplement, with smaller providers receiving the highest supplement. Large providers will receive a minimum payment amount based on a percentage of lost revenues and COVID-related expenses. HHS will determine the exact amount of the base payments and supplements after analyzing data from all the applications received to ensure available funds are distributed equitably.

Rural

HRSA will make $8.5B in rural payments to providers who serve patients who receive Medicaid, CHIP, and/or Medicare services in a rural area as defined by the HHS Federal Office of Rural Health Policy. Search the Rural Health Grants Eligibility Analyzer  to see what areas qualify as "rural" for the rural payments. 

Phase 3 Reconsiderations
Providers who believe their Phase 3 payment was not calculated correctly according to this methodology will now have an opportunity to request a reconsideration. Further details on this Phase 3 reconsideration process are forthcoming.

Grace Period for Reporting Period 1

In order to help providers come into compliance with PRF Reporting requirements if they miss the September 30, 2021 deadline for the first PRF Reporting Time Period, HHS announced a final 60-day grace period for those who received a PRF payment between April 10, 2020 and June 30, 2020.

It’s important to note that the deadlines to use funds and the Reporting Time Period are not changing. However, HHS will not enforce actions for noncompliant providers during the grace period. More information on reporting is available on the HRSA website. 

Additional Information:

Visit the HRSA website for more information about eligibility requirements, documents, and information providers will need to complete their application.

 

Agency-Level Hospice Quality Measure (QM) Reports Now Include Claims-Based Measures

QM Reports now include two measures based on Fiscal Year 2018 and 2019 Medicare claims data: the Hospice Care Index (HCI) and Hospice Visits in the Last Days of Life (HVLDL). Hospices can use the QM Report to learn about HCI and HVLDL and begin efforts to improve quality of care. Find the QM Reports in your CASPER folders in QIES, and find information about HCI and HVLDL measure specifications in the FY 2022 Hospice Wage Index and Payment Rate Update Final Rule on the Hospice Regulations and Notices page.

 

CMS Issues Additional Home Health Claim Processing Instructions (From NAHC)

The Centers for Medicare & Medicaid Services (CMS) has issued Change Request 12424 that provides additional instructions related claims processing for the notice of admission (NOA) for claims that span calendar years 2021 and 2022, and special circumstances for discharges when no visits are made in a subsequent 30 day period.

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