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U.S. Lifts Pause In Use Of J&J Vaccine After Vote By Expert Panel
Reported by NPR/Updated 04/23/2021
Use of the Johnson & Johnson COVID-19 vaccine is allowed again now that a panel of experts has voted to put it back in distribution despite rare blood clotting problems.
The Food and Drug Administration and the Centers for Disease Control and Prevention announced Friday after the panel voted that the vaccine is safe and effective at preventing COVID-19, and its benefits outweigh the known risks.
For 10 days the Johnson & Johnson COVID-19 vaccine had been in limbo as U.S. health authorities declared a recommended "pause" on administering the shot.
The CDC and the FDA decided to restart administering the single-dose vaccine and to recommend that anyone with concerns should consult their health care provider. The agencies said the chance of the blood clotting disorder is "very low" and has affected mainly women under age 50.
The CDC vaccine advisory committee did not recommend an additional warning. Several members expressed concerns that a warning could increase vaccine hesitancy, while others worried about the ramifications of not including a warning. That information will likely be added to the instructions and fact sheets for the Johnson & Johnson vaccine.
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COVID-19 Updates
Public Health Emergency Declaration Renewed
Secretary Becerra issued a nationwide “Renewal of the Determination that a Public Health Emergency Exists” on April 15, 2021, as a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) Pandemic. Read this announcement on the HHS Public Health Emergency website.
British Variant B.1.1.7. More Contagious
Science Daily reports, “A new study at Tel Aviv University found that the British variant (termed: B.1.1.7) of Covid-19 is 45% more contagious than the original virus.”
Pfizer and Moderna Both Say Booster Shots Will Probably Be Needed
WebMD Health News reports, “People who've received both doses of the Pfizer-BioNTech or Moderna coronavirus vaccines will probably need a booster shot this year, top executives for those two pharmaceutical companies said this week. Pfizer CEO said people who've gotten both doses would likely need a third shot within 12 months and might need an annual shot thereafter.”
Starting last Week, Rapid COVID-19 Home Tests to be Sold at Walmart, Walgreens, and CVS
USA Today reports, “Consumers will be able to buy rapid coronavirus tests without a prescription this week at three national chain retailers, an expansion that comes as the nation's vaccination effort accelerates and states relax distancing requirements and mask mandates. Abbott Laboratories' BinaxNOW coronavirus self-test kits will be shipped to CVS Pharmacy, Walgreens and Walmart locations, and also will be sold online. The two-test kit, which last month received Food and Drug Administration emergency-use authorization for serial screening, will cost $23.99, the company said.”
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7.4M Direct Care Jobs Will Need to Be Filled by 2029, with Most in Home Care
Home Health Care News By Andrew Donlan | April 12, 2021 The U.S. population is rapidly aging — a topic frequently visited by home-based care providers. But as they do age, direct care workers are going to need to care for them. And that won’t just require 1.3 million more individuals to enter the direct care workforce by the decade’s end; it will also require another 6.2 million additional workers to fill the empty slots made up by those who left, according to a new report from PHI. About 4.5 million of those will specifically be home care jobs. “This year’s employment projections are not that different than previous years, but that doesn’t make them any less shocking,” Stephen Campbell, a data analyst at PHI and the lead author of the report, told Home Health Care News in an email. “There will be more new jobs in home care than in any other occupation, but this workforce is among the least visible and most undervalued.”
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CMS Re-Specifies Hospice Visits in Last Days of Life Measure
The Centers for Medicare & Medicaid (CMS) has re-specified the Hospice Visits When Death is Imminent (HVWDII) measure. The re-specified measure, Hospice Visits in Last Days of Life (HVLDL), and was announced by CMS via the report Hospice Visits When Death is Imminent: Measure Validity Testing Summary and Re-Specifications (posted in September, 2020). HVLDL is a claims-based measure that indicates the hospice provider’s proportion of patients who have received visits from a registered nurse or medical social worker (non-telephonically) on at least two out of the final three days of the patient’s life. Hospices have had questions about the measure including calculation details and impact on Care Compare and future hospice submission requirements.
NAHC is consolidating some of the history on the change to the HVLDL, the questions many hospices have and responses in this article, and providing links to previous NAHC Report articles and other resources for the HVLDL.
Because CMS will utilize hospice claims for this measure, Section O of the HIS-Discharge record is no longer needed. This is the section that captured the hospice visit data. Therefore, CMS revised the HIS record to reflect the elimination of this section and updated the HIS Manual. The final HIS Manual V3.00 is available as is the updated HIS-Admission (updated to reflect current reporting year) and HIS-Discharge documents. The HIS Manual V3.00 is effective as of February 16, 2021 and the HVLDL is effective with admissions and discharges 1/1/2021 and later.
As reported previously, hospices may use and submit either V2.00 or V3.00 of the HIS-Discharge record for admissions and discharges on or after this date. Both are accepted by the ASAP system at this time. If V2.00 is submitted by a hospice, the ASAP system will not capture the visit information in Section O (CMS has stated it is not able to collect data it is not using). Some hospices have decided to continue using this version of the HIS-Discharge for their own internal visit data analysis and have not reported any problems with submission. CMS has not given a date as to when the ASAP system will no longer accept HIS-Discharge V2.00.
Members can follow the link below for some of the most frequently asked questions about the elimination of Section O from the HIS-Discharge and the HVLDL measure.
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What Medicare Advantage Plans Want From Home-Based Care Providers
Home Health Care News By Andrew Donlan | April 14, 2021 Medicare Advantage (MA) has provided tailwinds for home-based care providers, as the overall MA member population has grown substantially over the last decade. In 2020, there were over 24 million MA members in the U.S., over double the amount there were in 2010 and nearly five times the amount in 2005, according to Centers for Medicare & Medicaid Services (CMS) data. MA opportunities don’t grow on trees, however. Home-based care agencies are undoubtedly worthy in the continuum of care, but each provider has to prove its value to health plans looking to reduce costs and provide better care for their members. And from the health plan perspective, there is more than one thing they’re looking for, Greg Sheff, the SVP and CMO of Home Solutions for Humana (NYSE: HUM), said on a recent webinar hosted by the Advisory Board. “One thing is coming with outcomes data,” Sheff said. “From the payer’s perspective, we’re going to look at that and be cynical about it. [We’ll] want to test it and validate it with our own pilots with [the provider]. But talking about outcomes — and not just kind of the pitch on the model — is super important.”
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