In The News

Merck's COVID-19 pill significantly less effective in new analysis

By Manas Mishra and Michael Erman, Reuters

WASHINGTON — Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.

The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.

The lower efficacy of Merck's drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc's trial for its experimental pill, Paxlovid, showed an 89% reduction in hospitalizations and deaths.

Merck's shares fell 3.5% to $79.39 in morning trading.

Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.

The agency's staff did not make their own recommendation as to whether the pill should be authorized.

FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.

They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.

Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates…

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7 policies in Biden’s spending plan aimed at health equity

STAT News / Rachel Cohrs
WASHINGTON — Democrats have made big promises to tackle racial inequities across society, including in health care, since protests for racial justice swept the nation in 2020.
Until recently, it wasn’t clear how either lawmakers or the Biden administration would deliver on those goals — but some of the first concrete steps are now taking shape in the new spending plan Democrats are moving.
Embedded in the nearly $2 trillion plan are billions of dollars to help make health care services more accessible and affordable for Americans who slipped through the cracks of existing safety-net policies.
The health equity programs span the beginning of life, aiming to make birth safer for Black mothers, to the end, offering incentives to boost pay for home care services disproportionately provided by Black and Hispanic women. The package would also provide cheaper coverage options for low-income adults in states that haven’t expanded Medicaid under the Affordable Care Act — a population that is 60% people of color — and provide stable funding for coverage programs for children and people in the U.S. territories.
The package, dubbed the Build Back Better Act, has passed the House, but still has to clear the Senate without a single Democratic defection, and then will likely have to go to another vote in the House before proceeding to the president’s desk.
“This is historic legislation, and an incredible investment in health equity. There’s a lot of important provisions, and we need to get this across the finish line,” said Frederick Isasi, executive director of the consumer advocacy group Families USA.
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‘Be Vigilant’: What In-Home Care Providers Should Know About the Omicron Variant

Home Health Care News / By Robert Holly

The World Health Organization (WHO) on Friday officially designated the COVID-19 variant Omicron as “a variant of concern.” The U.N. agency on Monday followed that up by warning the global risk from Omicron is “very high” based on early evidence, noting the variant could have “severe consequences” as far as future surges.
While there’s still much to learn about Omicron, its emergence is yet another reminder that the pandemic is far from over for home health and home care providers. Additionally, it may be a glimpse at what the post-COVID world may look like without additional intervention.
“Be vigilant,” a LeadingAge spokesperson told in-home care providers in a message shared with Home Health Care News. “The pandemic is not over.”
Home-based care operators had already been preparing for a challenging winter prior to the discovery of the Omicron variant, first detected in South Africa with cases later confirmed in Scotland, Spain, Canada and other countries. Many were feeling relatively optimistic about the next few months as well, with the worst of the Delta variant largely behind them and staff-quarantine numbers starting to go down.
“The number of clinicians on quarantine has peaked,” Amedisys Inc. (Nasdaq: AMED) President and COO Chris Gerard said on a recent earnings call. “And entering Q4, we’re seeing the [quarantine] number decline rapidly to less than 1%, which is also encouraging.”
If Omicron ends up being anywhere near contagious as Delta, it could upend the current outlook. And it’s only a matter of time before the COVID-19 mutation makes its way to the U.S., according to President Joe Biden.
“Sooner or later, we’re going to see cases of this new variant here in the United States,” Biden said, speaking Monday from the White House. “We’ll have to face this new threat just as we face those who have come before it.”
Delta was first detected in India in late 2020. By August, it had spread to over 160 countries.
Despite targeting Omicron as high risk, WHO says it’s unclear whether the variant is more transmissible compared to Delta and previous COVID-19 mutations such as Alpha, Beta or Gamma. The agency similarly says it’s uncertain whether Omicron causes more severe disease compared to infections with other variants.
Dr. Anthony Fauci, Biden’s chief medical advisor for the pandemic, said it could be two weeks or more before further information about Omicron’s transmissibility and severity come to light. Early patterns, however, suggest Omicron likely spreads more easily, he said.
“If you look at the pattern of what’s going on right now in southern Africa — particularly in South Africa — when you have a spike of infections, they are very heavily weighted toward this new variant, the Omicron,” Fauci said during a Sunday TV appearance. “Therefore, you have to presume that it has a good degree of transmissibility advantage.”
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‘Hope for the Best, Plan for the Worst’: How Providers Should Plan Around the CMS Mandate Freeze

Home Health Care News 
By Andrew Donlan | December 1, 2021
The initial health care worker vaccine mandate laid out by the Centers for Medicare & Medicaid Services (CMS) was a cause for confusion for some home health providers when it was announced officially in early November. Now that a nationwide injunction has been issued by a federal judge with key deadlines rapidly approaching, that confusion has only intensified.
What’s more likely than the mandate completely going away, however, is an implementation delay.
“I think for the near-term future, until this is worked out in the courts, the mandates are not going to apply,” Angelo Spinola, the co-chair of the home health and home care industry group at the law firm Polsinelli, told Home Health Care News. “Right now, that means that these rules will not go into effect until and unless the injunctions are lifted, and that’s not going to happen until the matter is resolved.”
But that doesn’t mean home health providers should put their employee-vaccination efforts on pause.
The National Association for Home Care & Hospice (NAHC) is urging its provider members to continue on the path to compliance as the waiting game begins.
“We believe it is incumbent upon providers to operate in good faith throughout to achieve compliance,” NAHC said in a statement shared with HHCN. “It remains possible that the District Court rulings will be reversed and that the original compliance deadlines will be held in place. While that outcome is not highly likely, a good faith compliance effort will be the best protection a provider can have against any enforcement action. Should the administration take steps to directly suspend implementation and enforcement of the rule pending the outcome of the litigation, providers can then suspend efforts to comply with the CMS.”
In its statement, NAHC also advised the Biden administration to take steps to provide “needed clarity” to all health care providers subject to the rule, a group of about 76,000 Medicare and Medicaid organizations.
Litigation timeline
The length of the litigation process and any coinciding delays are highly relevant given that the deadline for health care workers to get fully vaccinated is a month away…
…The matter will not follow a normal litagary timeline, though. The courts are moving very quickly on the issues, which means they should be resolved in mere weeks at the earliest and a few months at the latest, Spinola said.
All three mandates are under fire right now: the Occupational Safety and Health Administration’s (OSHA) large-employer mandate, the federal contractor mandate and the CMS mandate for providers under Conditions of Participations (CoPs).
“I think that it’s probably pretty likely that the district court judges are going to rule that the mandate is not valid,” Spinola said. “Because to issue an injunction like this, it means that the judge believes that there’s a likelihood of success for the moving party, and therefore, they’re not going to put the rule into place until after the decision is made.”
After that, however, an appeal is likely. At that point, new judges – perhaps with different perspectives on the issue – will come into play. Ultimately, the vaccination-mandate battle could end up in the Supreme Court.

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Expression of Thanks from the Home Care and Hospice Association of Colorado

We hope everyone had a very Happy Thanksgiving with family and friends.

The HHAC Board and Staff have so much to be thankful for!

  • We are thankful for the dedicated frontline home care and hospice employees who have continued to go above and beyond during the last year of the pandemic; often putting their own needs behind those of others;
  • We are thankful to all the Administrators, Managers, and Office Personnel who continue to sacrifice in support of their clinical teams and clients/patients;
  • We are thankful for your loved ones who recognize how important your work is and support you through your long days/nights and work-related stress that sometimes come home with you;
  • We are thankful for all the health care providers in Colorado who partner with home care and hospice organizations to care for their clients/patients;
  • We are thankful for our local and national representatives, government employees, Advocacy and Communications teams who advocate for the expansion and increased support of home care and hospice services;
  • We are thankful for the hundreds of thousands of unpaid family caregivers in Colorado who voluntarily provide care to their family and friends to help them remain as safe and happy as possible at home;
  • We are thankful for our country’s Veterans and for the opportunity that you have to give back to them, in some measure, for their service and sacrifices;
  • We are thankful for both faith and science that help us get through life’s trials, including the ongoing global pandemic;
  • We are thankful for eyes to see and hands to help those who have lost loved ones to COVID-19 or other infirmities during the last year;
  • We are thankful for your support of the work that we do every day on behalf of HHAC members and home care and hospice in Colorado.  
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