Feds up COVID-19 funding dedicated to nursing homes to nearly $10B

The administration will be more than doubling funding dedicated directly to nursing homes to fight the coronavirus pandemic, thanks to an additional $5 billion announced by President Trump at a briefing Wednesday.

The $5 billion will be spread around the nation and providers will become eligible by participating in an online infection control training program. Twenty-three learning modules in the program will teach, among other things, cohorting strategies and promote the use of telehealth, the Centers for Medicare & Medicaid Services explained in a statement Wednesday.

Trump foreshadowed Wednesday’s announcement in comments delivered Tuesday in his first coronavirus briefing in more than three months, as earlier reported by McKnight’s Long-Term Care News.

The Department of Health and Human Services will devote $5 billion of the Provider Relief Fund authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act to Medicare-certified long-term care facilities and state veterans’ homes, with the goal of building nursing home skills and enhancing nursing homes’ response, CMS said.

The new Provider Relief Fund dollars announced Wednesday will come in addition to a specific $4.9 billion round of funding previously assigned exclusively to nursing homes. Skilled nursing operators also are in line to receive smaller funding packages under the aegis of the $2 trillion CARES Act package.

“Nursing homes in higher risk areas will be receiving more funding,” Trump said Wednesday. “This money can be used to address critical needs, including the hiring of additional staff, increasing testing and providing technology support so residents can connect to their families.”

“Mentorship” programs with subject matter experts also will come into play with the new funding, CMS announced.

The agency also said it will begin “requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week.” It said it believes such a move can slow the spread of COVID-19 through asymptomatic carriers working at facilities.

CMS Administrator Seema Verma, however, noted that imposing such a requirement would first have to go through formal rulemaking. She told reporters that this will occur “very shortly” but declined to be more specific on the timing.

More than 600 point-of-care testing devices will be shipped to nursing homes in hotspots this week, CMS also announced. It is less than one-third the number announced last week when HHS first unveiled its intention to equip every nursing home in the country with point-of-care devices, but that overarching goal remains in effect over the next several months, federal health officials said.

CMS also announced Wednesday that a first round of Task Force Strike Teams had been sent to some nursing homes that showed a rise in COVID-19 cases in Illinois, Florida, Louisiana Ohio, Pennsylvania and Texas from Saturday to Monday to “provide onsite technical assistance and education to nursing homes experiencing outbreaks.” The teams comprised clinicians and public health service professionals from CMS, the Centers for Disease Control & Prevention, and the Office of the Assistant Secretary for Health.

CMS and the CDC are jointly rolling out the 23-module online, self-paced Nursing Home COVID-19 training program focused on infection control and best practices. Facilities are encouraged to post government-provided verification “badges” on their websites to show proof of completion of the courses.

CMS also announced that the administration will be releasing a list of nursing homes showing an increase in COVID-19 cases on a weekly basis as part of a weekly governor’s report. This will be done to “ensure states have the information needed to target their support to the highest risk nursing homes,” the agency said. When a nursing home has three or more cases of COVID-19, the state will be alerted.

Providers respond

The leader of the largest nursing home association in the U.S. applauded the new-funding announcement in a statement Wednesday night.

“We appreciate the administration sending this much-needed funding to our nursing homes to help ensure our facilities have the personal protective equipment (PPE), access to testing and staffing needed to keep our residents and caregivers safe,” said Mark Parkinson, the president and CEO of the American Health Care Association / National Center for Assisted Living. “This funding is an important step forward for nursing homes in our fight against this deadly virus.”

He also repeated a push for an additional $100 billion relief fund from the administration for all providers.

LeadingAge President and CEO Katie Smith Sloan also welcomed the additional dollars headed toward nursing homes but said she still wants to see a more fully integrated effort from the administration.

“Tonight’s announcement of $5 billion for nursing homes from the Provider Relief Fund is a good next step, but any effort must be backed by a coordinated national plan that will help protect millions of older adults,” she said in a statement. “There are important unanswered questions about this program, including how far this funding will go to support the new mandate of increased staff testing. We look forward to learning more.”

BREAKING: Feds increase COVID-19 funding dedicated to nursing homes to nearly $10 billion

Nemaura Medical to integrate third party activity data to its glucose monitor

Nemaura Medical (NMRD +8.9%) has commissioned the integration of data from third party wearable devices into its proBEAT app which is planned for launch in the U.S. later this year.

proBEAT is a wearable non-invasive glucose monitor designed to collect glucose profiles and develop artificial intelligence-based prompts and feedback to users affecting their blood glucose levels.

https://seekingalpha.com/news/3594378-nemaura-medical-to-integrate-third-party-activity-data-to-glucose-monitor

Healthware launches global resource hub for COVID-19’s ‘new normal’

Healthware has launched a new online resource that aggregates information and analysis on how to respond to the huge changes COVID-19 has wrought across life sciences and healthcare.

The open access newnormal.health aims to help guide executives from pharma, biotech and medical device companies in their response to the pandemic and its aftermath.

Roberto Ascione, Healthware Group’s CEO, said: “The ‘new normal’ is a seismic shift for the life sciences industry and requires a transformation of how we conceive of healthcare that’s far broader than just an app or other piece of technology. We need to be thinking about how people, processes and policies need to change.”

The site contains content from Healthware and its partners, including pharmaphorum, and covers customer engagement, digital health, digital transformation, and trends and perspectives on future scenarios for the industry.

These include looking at how AI can help fight COVID-19, the ascent of telemedicine, drivers of change within pharmaceutical marketing and future roles for digital therapeutics.

“The special conditions that COVID-19 and its lockdowns generated have acted as a catalyst, accelerating companies’ existing digital transformations and speeding the uptake of telemedicine.

“Digital health and digital therapeutics were already growing, but only at a certain pace – the pandemic created a number of conditions that have massively accelerated that,” Ascione said.

He added that the need for home access to care, and the isolation of those affected or potentially affected by the virus, had demonstrated that remote monitoring of patients at home was possible.

At the same time, within the pharmaceutical industry, stranded field forces have been taking advantage of remote detailing to overcome their lack of physical access to healthcare professionals, adapting it to HCPs’ needs for meaningful information.

This has shown, Ascione said, “that promotion is not enough, you need to render meaningful services and move from push marketing to marketing-as-a-service as a baseline. That, to me, is part of the new normal when it comes to pharmaceutical companies”.

Newnormal.health will be regularly updated, including with a planned series of New Normal Talks that will feature one-to-one virtual fireside chats between experts from all side of the healthcare ecosystem.

Healthware launches global resource hub for COVID-19’s ‘new normal’

FDA approves Jazz Pharmaceuticals’ narcolepsy therapy

The FDA has approved Jazz Pharmaceuticals’ sleep disorder drug Xywav, to treat daytime sleepiness in patients with narcolepsy, offering a regime with less sodium than standard therapy.

Xywav (calcium, magnesium, potassium, and sodium oxybates) is an oral solution that has been approved in patients aged seven or older with narcolepsy.

Narcolepsy is a neurological disorder that involves a decreased ability to regulate sleep-wake cycles.

There is no cure and symptoms often include periods of excessive daytime and brief involuntary sleep episodes.

Dublin-based Jazz said it plans to launch Xywav by the end of the year after it puts into place a safety plan required by the FDA, which has identified the drug’s potential for abuse and misuse in a boxed warning.

Xywav will therefore be only available as part of a Risk Evaluation and Mitigation Strategy (REMS) as the FDA is sensitive to products that could be addictive in the light of the opiate addiction epidemic in the US.

FDA approval of Xywav is based on a a global phase 3 double-blind, placebo-controlled, randomised-withdrawal, multicentre study that demonstrated the efficacy and safety of Xywav in the treatment of cataplexy and EDS in patients with narcolepsy.

In the study, which enrolled 201 patients, Xywav demonstrated highly statistically significant differences in the weekly number of cataplexy attacks compared to placebo.

There are several dosing options available for adults and children – prescribers can titrate Xywav into unequal doses taken over the course of the night.

When patients start Xywav after sodium oxybate, Xywav treatment is begun at the same dose and regimen as sodium oxybate (gram for gram) and titrated as needed based on efficacy and tolerability.

Xywav is formulated to have 92% less sodium than sodium oxybate, the current standard of care for the condition.

Unlike sodium oxybate, Xywav does not contain warnings about high sodium content.

Richard Bogan, associate clinical professor at the University of South Carolina School of Medicine and lead investigator of the phase 3 study, said: “Xywav makes it possible for patients to have a lower-sodium oxybate treatment option.

“This may help patients taking sodium oxybate better align with daily sodium intake recommendations including those by the American Heart Association.

“The average American consumes too much sodium. Excess sodium intake has been linked with increases in blood pressure, hypertension, stroke and other cardiovascular disease.”

FDA approves Jazz Pharmaceuticals’ narcolepsy therapy

Sorrento picks up another bear who doubts COVID-19 ‘cure’

Lakewood Capital has established a short position in Sorrento Therapeutics (SRNE +0.6%), joining a growing list, citing its “checkered” history and “opportunistic claims to have a cure for COVID-19.”

Shares quadrupled in mid-May after the company announced that it discovered an antibody, dubbed STI-1499, that, it claimed, could provide 100% inhibition of SARS-CoV-2. Shares peaked at $10.00 the next day but retraced to a low of $3.82 on June 4 before starting a new up trend.

Observers, including STAT’s Adam Feuerstein, Vital Knowledge and Hindenburg Research, were quick to question the veracity of the company’s claims.

https://seekingalpha.com/news/3594359-sorrento-picks-up-another-bear-who-doubts-covidminus-19-cure

COVID-19 Vaccines May Require Two Doses, House Members Told

Several COVID-19 vaccines currently under development may require more than one dose in order to be effective, pharmaceutical company executives told a House subcommittee on Tuesday.

Pfizer anticipates that the vaccine the company is taking to a pivotal trial “will use an initial dose plus a booster — so yes, two doses,” said John Young, the company’s chief business officer, testifying at a hearing held by the House Energy & Commerce Oversight and Investigations Subcommittee.

At AstraZeneca, “our data suggest two doses give a stronger immune response than one, but until we understand the correlates of immune detection, we don’t know whether one will be enough,” said Menelas Pangalos, PhD, executive vice president for biopharmaceutical research and development at the company. “We’ll go with two to be sure, but it could end up becoming one dose.”

“That’s really helpful for us and the public to understand,” said Rep. Greg Walden (R-Ore.), ranking member of the full Energy & Commerce Committee. “When we talk about having 300 million doses or 30 million doses, we probably should cut that in half in terms of the number of people that are actually going to be able to get vaccinated in worst-case scenarios.”

Some companies are pursuing a different strategy; witness Julie Gerberding, MD, executive vice president and chief patient officer at Merck, said that her company has “selected vaccine candidates we hope will be single-dose.”

Concerns About the Short Timeframe

Several committee members expressed concern about the possible consequences of a shortened timeframe for developing vaccines.

“We all want a COVID-19 vaccine to be developed as soon as possible, but before a vaccine is distributed, public health experts must ensure that it is safe, effective, and available to all who need it,” said Rep. Frank Pallone (D-N.J.), chairman of the full Energy & Commerce Committee. “My fear is that FDA will be forced by the Trump administration to approve a vaccine that lacks effectiveness.”

Witnesses disputed that idea. “All of our interactions with the regulators have given us no evidence that they’re lowering the standards or thinking about lowering the standards,” said Pangalos. “Remember, this is going to be a vaccine that’s going to be used globally, so every regulatory authority is going to have a view on efficacy and safety of our vaccine.”

We do believe it’s going to be possible in a safe way to bring forth an effective vaccine in 12-18 months,” said Stephen Hoge, MD, president of Moderna. “We’ve been working around the clock … to make sure we’re doing this in an incredibly responsible way all the way through.”

Pfizer, Moderna Farthest Along

As for progress on a vaccine, Pfizer and Moderna seemed to be leading the pack.

Pfizer is hoping to begin its phase III trial this month, said Young. “There are encouraging early signs, but there is a lot more work left to do.” If all goes well, “we hope to be able to provide a dossier of clinical data from our large phase IIb/III study to the FDA in October,” and see whether it meets the FDA’s requirement for an emergency use authorization; the company hopes to deliver up to 100 million doses globally in 2020 and 1.3 billion doses in 2021, he said.

Hoge said Moderna’s phase III trial on its vaccine candidate “is a little beyond our control in terms of timing,” but presuming the company can accrue cases quickly, “we hope in the fall or towards the end of the year we would have data we can submit to the FDA.”

Macaya Douoguih, MD, head of clinical development and medical affairs at Janssen Vaccines and Prevention, said her company “is targeting to at least have results by early 2021 and have 100 million doses by the end of March, while Gerberding said Merck “expects to be in clinical trials imminently, but wouldn’t expect to have a licensed product until 2021 at the earliest.”

Rep. Jan Schakowsky (D-Ill.) said she was concerned about how expensive the vaccine would be and asked the witnesses whether their companies would agree to sell the vaccine at cost.

Hoge said Moderna would not do so, as did Gerberding, while Pangalos said under the agreement AstraZeneca has with the Biomedical Advanced Research and Development Authority (BARDA) to produce 300 million doses of a vaccine, it will be selling the vaccine to the government “at no profit.” Douoguih said Janssen will be providing its vaccine at a “not-for-profit price” during the pandemic.

Young said that Pfizer recognizes that “these are extraordinary times and our pricing will reflect that during the term of the pandemic; we’ll price our potential vaccine consistent with the urgent global health emergency that we’re facing,” but added that the company also believes the vaccine “should be free to the public. A vaccine is meaningless if people are unable to afford it.”

Developing a Distribution Plan

Several committee members wanted to know whether the companies had plans for how to prioritize who would receive the vaccine first.

“We should be able to develop a distribution plan based on public health principles to slow transmission,” said Rep. Raul Ruiz, MD (D-Calif.). “We need to ask, where is the highest risk and highest rate of transmission, and which communities are dying at a disproportionate rate of coronavirus? It’s not too difficult to find the answers to those questions … We need public health principles based on public health equity — not politics, not profit, not going to the highest bidder for objectives that favor the powerful and wealthy.”

Shortly after the hearing ended, the National Academy of Medicine announced that it was launching a committee to study the equitable allocation of any COVID-19 vaccine developed; the committee’s first meeting is Friday.

Rep. Buddy Carter (R-Ga.) raised the question of whether the drugmakers were sourcing their raw materials and other supplies from foreign countries. “This is a serious issue,” Carter said. “I think we should do everything we can to domesticate manufacturing.”

Pangalos said all of his company’s U.S. supply chain “comes from the U.S.” Gerberding said that Merck’s supply chain “is generally very much localized to the U.S. and a couple of places in Europe, but I need to verify the entirety of the supply chain.” Hoge said Moderna’s vaccine is “made entirely in the U.S.,” but some supplies for the vaccine’s raw materials are being procured internationally, mostly from Europe.

Rep . Susan Brooks (R-Ind.) asked about how the companies planned to overcome vaccine hesitancy.

“Efforts need to start now in terms of education and outreach,” said Douoguih. “Of course we have to develop a safe and efficacious vaccine, and be confident the data we’re presenting are shared in an understandable and digestible way so that people feel comfortable in accepting a vaccination, but I do think that communities that are disproportionately affected might require more engagement, and that’s a long process that really needs to start now such that they could even consider participating in clinical trials.”

“For Pfizer, data transparency is really important,” said Young. “One of the commitments we made early on in this pandemic is to publish transparently our clinical data … We’re also looking to ensure that our pivotal study is representative of the burden of disease for COVID-19, so recruitment of minorities, of women, of older patients into the study is going to be really important. That’s critical so that when that trial completes and when we follow up with those patients … the grass roots of America can be confident that a vaccine that is approved is going to be safe and effective for patients.”

https://www.medpagetoday.com/infectiousdisease/covid19/87678