Home healthcare agency to take COVID-19 referrals from hospitals

The Visiting Nurse Service of New York is accepting COVID-19 referrals from local hospitals. The goal is to offset some of the burden.

The approach comes with challenges, however.

“We want to do everything possible to alleviate the strain on the New York metro area’s hospital system,” said Michael Bernstein, executive vice president and chief administrative officer at VNSNY.

For COVID-19 patients who are stable enough to be discharged after a hospital stay, VNSNY will provide home care for their flulike symptoms and underlying medical conditions such as diabetes and chronic obstructive pulmonary disease. The intent is to free up hospital beds for patients who are in serious condition and need ventilators.

“We are working rapidly to deploy more telehealth and remote patient visits,” Bernstein said. Using virtual services for some routine visits enables more staff members to visit COVID-19 patients’ homes.

The organization spent about $200,000—an unbudgeted expense—to secure additional tablets and equipment for remote patient monitoring, he said. And it’s spending hundreds of thousands of dollars more to buy personal protective equipment.

On top of masks, gowns and gloves, equipment needed to safely care for COVID-19 patients in their home includes disposable thermometers, stethoscopes and blood-pressure cuffs.

VNSNY will keep the equipment at patients’ homes. Kits—which need to be replenished after five visits—also include 13-gallon trash bags for safely removing and disposing of materials.

As an extra precaution, home care visits for COVID-19 patients are being scheduled at the end of the workday.

Aside from home care, VNSNY has begun providing hospice care for patients with the virus.

To help home care agencies better ease the burden hospitals are facing, Bernstein called for the federal government—with the support of state government—to ensure that agencies are using telemedicine to safely take care of other patients while diverting resources for those with the virus.

“It’s critically important for the entire home care industry to be able to provide telehealth services and get fairly reimbursed for it,” he said. The federal Centers for Medicare and Medicaid Services has not ruled that remote patient monitoring is a billable way to provide service.

“Home care is the infantry: We go into the field. We go into people’s homes,” Bernstein said. “As long as we are equipped with the right personal protective equipment, that’s what we can do. And that can help alleviate the strain on the healthcare system.”

https://www.modernhealthcare.com/providers/home-healthcare-agency-take-covid-19-referrals-hospitals

Joint makers report pandemic pain

Sales of implants are set to fall sharply as non-urgent procedures are deferred.

For some medtechs the Covid-19 crisis has spurred demand for services: those that make the tests for coronavirus infections; makers of ventilators necessary to aid patients’ breathing; or telemedicine developers whose technology has taken off at a time when doctors can only see in person the most seriously ill.
Many more device companies, however, are being hit hard. As hospitals fill with the desperately sick, other patients requiring elective surgery are postponing their operations. Orthopaedics groups in particular are suffering. Companies including Stryker and Smith & Nephew withdrew their 2020 revenue guidance this week, conceding that use of their products would fall throughout the year.
In an SEC filing on Tuesday Stryker said it was withdrawing its first-quarter and full-year 2020 sales growth and earnings per share guidance, originally posted at the end of January. The group blamed the “unprecedented” measures that have been enforced by various governments to slow the spread of the virus, including the deferral of elective procedures and restrictions on social contact.
Joint deconstruction
Stryker will likely see the greatest effect on its hip and knee implants and endoscopy products, since the procedures these are used for are relatively easy to defer by a few months.
These products made up around a third of its total sales last year. Its trauma, extremities and spine businesses will be less severely affected since these are more often used in emergency surgeries, and the same goes for its neurovascular devices that are used to treat strokes.
The pandemic might also hit another aspect of the group’s business: its $5.4bn takeover of Wright Medical, currently slated to close in the second half (A Covid-19 threat to business acquisitions, 3 April 2020). The SEC filing does not mention the acquisition, so perhaps Stryker thinks the deal will conclude on schedule. Most of Wright’s sales come from devices to treat extremities – upper extremities such as shoulders in particular – so it could be affected slightly less than Stryker itself.

The top five joint reconstruction companies
	Annual sales ($bn)
Company	2019e	2024e	CAGR
Zimmer Biomet	5.0	5.9	+3%
Johnson & Johnson	3.3	3.8	+3%
Stryker	2.8	3.3	+3%
Smith & Nephew	1.7	2.1	+3%
Wright Medical Group	0.8	1.3	+9%
Source: EvaluateMedTech.

In fairness to Smith & Nephew, when it announced its 2020 outlook in February it did so with the proviso that the Covid-19 “situation normalises early in Q2”. This now being impossible, the group says that in China elective procedures have restarted,but remain considerably below pre-outbreak levels. In Europe and the US, though, all but the most urgent surgical procedures have been halted.
The UK group now expects underlying revenue growth for the first quarter to be around 8% down year on year, and its second-quarter sales and first-half trading margin will be “substantially down”.
Exposure 
The makeup of S&N’s business makes it far more exposed than Stryker; almost all its products are used predominantly in non-urgent procedures. Joint reconstruction devices made up about a third of S&N’s sales last year and endoscopy another third; its other main business, wound care, accounted for a quarter of revenues. Some of its wound care products will be used for injuries requiring immediate treatment but many are used to treat wounds resulting from joint arthroplasties – which are not now happening.
A contract with the UK government to build a new kind of ventilator specifically designed to allow large-scale production is good news, but will fall far short of making up for its orthopaedics losses. The OxVent device is under review by the UK’s MHRA; if approved, it will be made at S&N’s advanced wound management facility in Hull, UK.
Other orthopaedics companies rowing back their guidance include Conformis, which has furloughed around a third of its employees, stating that demand for arthroplasty has dropped significantly. Another tiny firm, Orthopediatrics, has withdrawn its guidance too. Intriguingly Othopediatrics has decided that this is a good time for M&A: yesterday it bought Apifix, which makes a device to treat young people with scoliosis, for $39m in cash and stock.
The effects of the pandemic on device sales will be felt in all sectors. Boston Scientific, mainly a cardiology company, and the patient monitoring specialist Masimo, have already abandoned prior guidance. Many more medtechs will have to do the same in the days to come.

Medtechs that have withdrawn guidance
Date guidance withdrawn	Company	Sector	Former guidance for 2020 revenues	Former guidance for organic growth
April 1	Masimo	Patient monitoring	$1.035bn	11 – 11.4%
March 31	Stryker	Orthopaedics; endoscopy; surgery; neurology	–	6.5 – 7.5%
March 30	Smith & Nephew	Orthopaedics	–	3.5 – 4.5%
March 30	Boston Scientific	Cardiology; endoscopy; neurology; respiratory; urology	–	6.5 – 8.5%
March 30	Orthopediatrics	Orthopaedics	–	22 – 24%
March 23	Conformis	Orthopaedics	–	3 – 6%
March 19	Exact Sciences	In vitro diagnostics	$1.61 – 1.65bn	–
Source: company communications, SEC.

https://www.evaluate.com/vantage/articles/analysis/spotlight/joint-makers-report-pandemic-pain

Cognitive Decline and Poor Glycemic Control Go Hand-in-Hand

Poorer glycemic control was tied to cognitive decline following a lacunar stroke in a prospective cohort study.
Among 942 individuals with type 2 diabetes who had a lacunar stroke, every 1% higher HbA1c was tied to a 0.06 drop in cognitive function at baseline measured by Cognitive Assessment Screening Instrument (CASI) z-score (95% CI -0.101 to -0.018), reported Tali Cukierman-Yaffe, MD, MSc, of Sheba Medical Center and the Sackler School of Medicine of Tel Aviv University in Israel.

This relationship was significant even after adjusting for demographic factors and clinical factors such as depression, hypertension, hyperlipidemia, body mass index, cardiovascular disease, obstructive sleep apnea, diabetic retinopathy, nephropathy, insulin use, and white matter abnormalities.
And those who started with higher average HbA1c levels at baseline tended to have lower cognitive functioning scores over time (P for interaction=0.037), Cukierman-Yaffe noted in her presentation at the virtual ENDO 2020 meeting sponsored by The Endocrine Society.
This association wasn’t stagnant either, as a 1% increase in HbA1c during follow-up was tied to a decrease in Cognitive Abilities Screening Instrument (CASI) score by approximately 0.021 points (95% CI -0.0043 to -0.038) over time.
This relationship between higher glucose levels and poorer cognitive functioning extended beyond just CASI z-score, as well, Cukierman-Yaffe noted. Higher HbA1c levels were also tied to significantly poorer performance in other psychological tests, including the clock making test of executive functioning, test of discriminative ability, and for the test of verbal fluency.

The prospective cohort analysis drew upon data from the individuals who participated in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. This included adults over the age of 30 — mean age of 63 — with an existing diagnosis of type 2 diabetes and a recent, symptomatic MRI-defined small subcortical ischemic stroke. These individuals had no evidence of cortical strokes, nor any evidence of severe cognitive functional impairment.
Many possible explanations could be underlying these significant associations seen in this study, she explained, also pointing out that this relationship is likely bidirectional.
“It may be that individuals with cognitive impairment have difficulty managing their [diabetes] disease, and thus have worse glucose control,” she stated, adding that “second, hyperglycemia may accelerate the rate of cognitive decline by either reducing capillary reperfusion or accelerating large vessel disease, or directly damaging the brain.”
But nonetheless, further research is needed to delve into these associations, she suggested. Future studies are not only needed to confirm these results, but also intervention studies should be done to delineate whether better glucose control could possibly slow the rate of cognitive declines in high-risk populations, such as this one.

In the meantime, Cukierman-Yaffe told MedPage Today that healthcare providers should be evaluating older patients with diabetes for cognitive decline, according to current guidelines from the American Diabetes Association, The Endocrine Society, and several more international societies.
“Cognitive assessment should be part of the routine check-up of older people with diabetes,” she said, noting that this is particularly important for two reasons: the relationship between cognitive dysfunction and self-care, and the fact that cognitive dysfunction is another one of many possible complications of diabetes posing a larger threat to older patients.

Disclosures

The study was supported by a grant from the National Institutes of Health.
Cukierman-Yaffe reported relationships with Sanofi, AstraZeneca, MSD, Lilly, and Medtronic.

Primary Source

Endocrine Society

Source Reference: Cukierman-Yaffe T, et al “The Relationship Between Glucose Control & Cognitive Function in People with Diabetes After a Lacunar Stroke” ENDO 2020; Abstract MON-636.

https://www.medpagetoday.com/meetingcoverage/endo/85768

Fate Therapeutics up 23% after hours on J&J cell therapy deal

Fate Therapeutics (NASDAQ:FATE) inks a global collaboration and option agreement with Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech aimed at developing cell therapies for cancer.

The partnership will leverage the company’s induced pluripotent stem cell (iPSC) platform with Janssen’s proprietary antigen-binding domains in up to four tumor-associated antigen targets that will be used to create novel CAR NK (natural killer) and CAR T-cell product candidates.

Fate will advance the candidates through the IND stage after which Janssen will have the option to exclusively license development and commercialization rights. Fate will be largely responsible for manufacturing which will be funded by Janssen.

Under the terms of the deal, Fate will receive $50M upfront, up to $1.8B in development and regulatory milestones, up to $1.2B in commercial milestones and double-digit royalties on net sales. It also has the right to co-commercialize each candidate in the U.S. and equally share in profits and losses. And finally, Janssen will invest $50M in Fate common stock at $31 per share (today’s close was $21.07).

https://seekingalpha.com/news/3558035-fate-therapeutics-up-23-after-hours-on-j-and-j-cell-therapy-deal

White House to recommend cloth masks amid COVID-1

STAT reports that the Trump administration, based on guidance from the CDC, is expected to announce a new policy urging Americans to wear cloth masks in an effort to prevent the spread of COVID-19.

The CDC recommended the public use homemade face coverings considering the enormous demand for N95 masks and related gear from healthcare workers.

Alpha Pro Tech (NYSEMKT:APT) is down 15%.

https://seekingalpha.com/news/3557968-white-house-to-recommend-cloth-masks-amid-covidminus-19

President invokes DPA on more companies for ventilator production

General Electric (NYSE:GE), Hill-Rom (NYSE:HRC), Medtronic (NYSE:MDT), ResMed (NYSE:RMD), Royal Philips and Vyaire Medical are the latest manufacturers subject to the Defense Production Act to manufacture needed ventilators.
https://seekingalpha.com/news/3557987-president-invokes-dpa-on-companies-for-ventilator-production

Emergent Bio teams up with feds to expedite plasma therapy for COVID-19

Emergent BioSolutions (NYSE:EBS) inks a formal agreement with the U.S. government aimed at speeding up the development of a plasma-based therapy, COVID-HIG, a human hyperimmune (contains a lot of antibodies against SARS-CoV-2) product for the potential treatment of severely ill COVID-19 patients and high-risk acute symptomatic patients to prevent progression to severe symptoms.

The company has initiated plasma screening and collection and intends to seek emergency use authorization from the FDA.

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) will provide $14.5M in funding to support development.

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has agreed to incorporate COVID-HIG into one of its clinical trials.

https://seekingalpha.com/news/3558007-emergent-bio-teams-up-feds-to-expedite-plasma-therapy-for-covidminus-19