Telehealth claims dipped in May, but still up 5,680% from year ago

• The volume of telehealth-related medical claims in May was not as high as April, but still vastly outpaces a year ago, according to insurance claims data from nonprofit Fair Health. Altogether, telehealth-related care comprised 8.7% of private claims, compared to 0.15% in May 2019 – an increase of 5,680%. That compares to 13% of all claims in April of this year, a drop of about one-third.
• Mental health comprised almost 40% of all diagnoses in May, up from 38.4% in May of last year and 34.1% in April 2020. Despite the current COVID-19 pandemic, respiratory diseases and infections were not within the top five diagnoses, even though they comprised 17.2% of diagnoses in May 2019.
• Although the use of telehealth services appears to be ebbing, the data suggest that telehealth will represent a significant share of healthcare services in the U.S. for the foreseeable future.

Use of telehealth services took off like wildfire beginning in March, as much of the U.S. went under shelter-in-place orders in response to the COVID-19 pandemic.

Although the volume of virtual encounters declined in May compared to April, the volumes remain significant, according to Fair’s repository of 31 billion private insurance claims. States began to reopen that month, likely accounting for the pullback in telehealth use.

Telehealth usage trends are also beginning to show that many Americans are under significant psychological distress. Mental health diagnoses were the leading use of mental health services in May, up 12.6% compared to April, Fair found.

Psychotherapy, which was not among the top five telehealth-related healthcare services in May last year, were two of the top five services in May this year.

The policies of some commercial insurers also appear to be promoting mental health services: 24% of individual health insurers and 10% of the group insurers expanded mental health services delivered through telehealth platforms, according to a new survey by Peterson-KFF.

The boon in virtual care is also scrambling the competitive landscape, evidenced by this week’s news that Teladoc plans to spend some $18.5 billion to acquire chronic care management firm Livongo.

Regulatory hurdles to virtual care are also falling. President Donald Trump earlier this week signed an executive order directing his health administration to implement permanent broader telehealth coverage beyond the current health emergency. Following suit, CMS quickly released new rules to put nine new telehealth payment codes on the books.

https://www.healthcaredive.com/news/telehealth-claims-dipped-in-may-but-still-up-5680-from-year-ago-fair-he/583109/

Healthcare gains jobs in July, but still down 800K from February

• Healthcare added 126,000 jobs in July with notable gains for dentists (+45,000), hospitals (+27,000) and physicians’ offices (+26,000). That’s slower than June’s growth of 358,000 healthcare jobs, and the industry is still about 800,000 jobs short from February’s levels.
• Nursing home job losses deepened with 28,000 more in July after losing 18,000 in June. Home healthcare services saw more gains with 16,000 new jobs in July, after 18,000 in June.
• Overall, the unemployment rate fell to 10.2%. It’s steadily decreasing since April’s peak of 14.7%, but still a far cry from February’s low of 3.5%.

Healthcare job growth slowed in July, reflecting some effects of new coronavirus hotspots in late June that forced more shutdowns and overwhelmed hospitals in Sun Belt states.

The sector lost 43,000 jobs in March, then another 1.4 million in April, but began slowly boomeranging back in May, June and now July.

July’s jobs report released Friday by the U.S. Bureau of Labor Statistics show ambulatory, outpatient and medical and diagnostic lab service jobs are returning near the levels they were at last year. Hospitals too are recovering from sharp losses earlier this year and approaching previous levels, adding 27,000 more jobs in July.

The same goes for dentists who faced steeped losses at the height of spring’s lockdowns, slashing half a million jobs in April. And while most healthcare jobs appear to be returning, they’re still about 800,000 jobs short from February’s levels.

Erica Groshen, former BLS commissioner and current senior labor economics advisor at Cornell’s School of Industrial and Labor Relations, said the net loss in healthcare jobs could be attributed to people continuing to put off routine and preventive healthcare.

“I haven’t had my teeth cleaned now for about 8 or 9 months,” Groshen said. “If we all put off these things for a long time, then those offices are running at smaller capacity. Then on top of that they’ve had to change their business models to not have as many people in the waiting room and serve fewer people over all. Both demand and capacity have shrunk.”

Certain healthcare services that have previously been delivered in group settings such as group therapy or physical therapy have also been stymied by lockdowns and social distancing measures, Groshen said.

According to BLS, healthcare jobs are projected to grow 14% from 2018 to 2028, much faster than the average for all occupations. It’s still unclear how the pandemic will affect that in the long term.

https://www.healthcaredive.com/news/july-healthcare-jobs-gains-BLS/583148/

Businesses and states launch own relief funds as congressional talks stall

As negotiations between Democrats and Republicans over a new round of coronavirus relief drag on with little hope of a quick resolution in sight, some businesses are stepping in to help out-of-work employees pay the bills.

Dozens of businesses that have been sidelined by lockdown orders have created funds to support their employees in recent weeks, after gridlock on Capitol Hill left an added unemployment benefit expire at the end of July.

Self Esteem Brands, a Minneapolis-based fitness company that owns Anytime Fitness and The Bar Method, will offer one-time grants of $500 to employees. An owner of Great Clips franchises in Central Texas is paying employees who have been furloughed. The University of Oregon seeded an employee relief fund with $50,000 last week, more than half of which has already been distributed.

“This year has been incredibly challenging for our members, employees, franchise owners and their staffs and our communities,” Chuck Runyon, Self Esteem Brands’ chef executive, said in a release announcing his firm’s $1 million fund. The fund “is a way that we can help them navigate this uncertainty as our franchise owners, clubs and studios work to adapt to a new normal in the fitness and wellness industry.”

The new programs are a sign of just how many Americans have suffered during the coronavirus pandemic and the economic recession that has followed — and how close the nation is to a catastrophe of layoffs, evictions and widespread food insecurity.

More than half of American households have lost income or jobs during the pandemic, according to the Census Bureau’s Household Pulse Survey. Black and Hispanic families, those without a college degree and younger people are disproportionately likely to say they have lost employment or wages.

About 10 percent of Americans who pay either rent or a mortgage were unable to make payments or had payments deferred last month, the Census Bureau survey found. About 15 percent said they had no confidence or only slight confidence in their ability to pay next month’s mortgage or rent, as eviction moratoria are set to expire in many states.

Already, an estimated 14 million households with children under the age of 18 say they do not always have enough food. Almost 11 million households said they were not confident they would be able to afford food over the next four weeks.

Absent Congressional action, some states are stepping in with their own grants. California legislators are debating a package that would entirely replace the expired $600 weekly benefit for workers who are out of a job.

“If that benefit is working in the short term, I don’t know why we’re stopping it, because the last thing we need is thousands of people evicted onto the streets,” Assembly Budget Committee chairman Phil Ting (D) told a local television station last week.

Pennsylvania last month unveiled a $50 million grant program to employers that provide hazard pay bonuses to front-line workers. Vermont Gov. Phil Scott (R) rolled out his version of a similar program this week, a $28 million fund to supplement the salaries of health care and public safety workers. Louisiana doled out one-time payments of $250 to front-line workers earning less than $50,000 a year.

In Oregon, Gov. Kate Brown (D) launched a fund to pay agricultural workers either recovering from or self-quarantining after being exposed to the coronavirus.

Other states are likely to face more pressure to provide relief as August drags on and Congress remains stalemated. There are few signs that the House, which has passed a $3 trillion package, and the Senate, which has introduced but not passed a $1 trillion package, will agree to terms with the White House anytime soon.

“We understand where we are and where they are,” Treasury Secretary Steven Mnuchin told reporters Thursday. “I think there’s a lot of issues we are close to a compromise position on, but I think there’s a handful of very big issues that we are still very far apart.”

https://thehill.com/homenews/state-watch/511067-businesses-and-states-launch-own-relief-funds-as-congressional-talks

Decentralised trials – aided by tech – could boost clinical research

Bringing clinical trials to patients – rather than the reverse – could be the key to improving recruitment into studies and making them faster, cheaper and more likely to succeed, according to one clinical research organisation (CRO).

There’s already plenty of support from regulators for virtual or ‘decentralised’ trials, including from former FDA Commissioner Scott Gottlieb who said last year that the agency was encouraging adoption of this approach to make trials more “agile and efficient”, as well as patient-centric.

Since the coronavirus pandemic interest in decentralised or hybrid trials that can include a combination of in-home clinical visits from healthcare professionals, direct to patient support and digital healthcare has been renewed, says CRO ICON in a new white paper

The trouble is, clinical researchers have been talking about the shift to decentralised trials for years, but haven’t been so effective at putting the idea into practice, it adds.

Some obstacles to take-up have been trial sponsors’ fears of liability if a problem arises during a home visit by a clinical investigator, finding suitable staff to carry out home visits, and jeopardising relationships with clinical site teams.

There’s a pressing need to improve efficiencies, given that the cost of bringing a single drug to market has increased 145% from about $800 million to $2.6 billion in the past 10 years, says ICON.

A big part of that escalation in costs is the cost of running trials, with 86% of all studies failing, and inadequate subject recruitment and high dropout rates cited in 85% of those failures.

Prior surveys suggest that the location of a clinical investigation site is a key consideration for almost two-thirds of trial participants, while four out of five organisations conducting or sponsoring studies said that having reliable transportation is important for subject recruitment and retention.

There’s little doubt that for most patients, participating in studies from the comfort of their own home – either from a visiting investigator or via digital means such as phone or online contact – is preferable to clinic visits.

For instance, the decentralised approach avoids disruption to school, work or other obligations, expands the pool of subjects to include those who have mobility problems, and allows visits or consultations during evenings, weekends or holidays when investigator sites may be closed.

That in turn could increase the success of clinical trials, shorten development timelines and potentially allow new treatments to be brought to market more quickly, says ICON.

Decentralised trials – aided by tech – could boost clinical research

CanSino to start Phase III trial of COVID-19 vaccine in Saudi

Saudi Arabia will soon begin Phase III clinical trials on around 5,000 people for a COVID-19 vaccine developed by China’s CanSino Biologics Inc, a Saudi health ministry spokesman said on Sunday.

Last month, CanSino’s co-founder said the company was in talks with Russia, Brazil, Chile and Saudi Arabia to launch a Phase III trial of the vaccine candidate, Ad5-nCOV.

The vaccine uses a harmless cold virus known as adenovirus type-5 (Ad5) to carry genetic material from the coronavirus into the body.

Researchers said last month that CanSino’s vaccine, co-developed with China’s military research unit, appeared to be safe and induced immune responses in most subjects.

Saudi Arabia plans to test the vaccine alongside a placebo on 5,000 volunteers and is currently preparing trials in the cities of Riyadh, Dammam and Mecca, Saudi state news agency SPA said on Saturday.

No COVID-19 vaccine has been approved for commercial use.

CanSino’s candidate became the first in China to move into human testing in March but other potential vaccines developed by Sinovac Biotech and a unit of China National Pharmaceutical Group (Sinopharm) have already been approved for Phase III trials overseas.

https://www.reuters.com/article/us-health-coronavirus-saudi-cansinobio/cansino-to-start-phase-iii-trial-of-covid-19-vaccine-in-saudi-idUSKCN2550L9

Biotech week ahead, Aug. 10

Biotech stocks advanced in the week ended Aug. 7, buoyed by multiple catalysts. Aside from the broader market strength, mostly positive earnings and continuing coronavirus treatment/vaccine news flow supported the move to the upside.
Novavax, Inc.’s NVAX 1.67% stretched valuation got further stretched as the shares added about 20% for the week in the wake of its interim Phase 1 readout for its coronavirus vaccine candidate.
Bristol-Myers Squibb Co BMY 0.47% reported a beat-and-raise quarter, with the shares receiving further support from a win in the patent lawsuit over its blood thinner Eliquis.
The week also saw a medical technology and two biotechs debuting on the Wall Street.
Here are the key catalysts for the unfolding week.

Conferences

BTIG Virtual Biotechnology Conference: Aug. 10-11
Wedbush PacGrow Healthcare Virtual Conference: Aug. 11-12

PDUFA Dates

The FDA is said to rule on the NDA filed by Bausch Health Companies Inc BHC 10.41% for EM-100, an investigational therapy for allergic conjunctivitis. The company had licensed this preservative-free ophthalmic solution from Eton Pharmaceuticals Inc ETON 1.78%. (Monday)
The agency is also due to announce its decision on Fennec Pharmaceuticals Inc’s FENC 3.92% NDA for Pedmark, which is being evaluated as a treatment option for chemotherapy-induced ototoxicity. (Monday)
FDA’s decision on label expansion for Roche Holdings AG’s Basel ADR Common Stock RHHBY 0.97% Xolair for the treatment of nasal polyps could come Tuesday, based on 10 months from the submission of the sBLA.

Adcom Calendar

FDA’ Oncology Drug Advisory Committee will discuss Thursday Mesoblast limited’s MESO 3.48% BLA for remestemcel-L for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

Earnings

Monday

• Rubius Therapeutics Inc RUBY 0.19% (before the market open)
• Reata Pharmaceuticals Inc RETA 2.83% (before the market open)
• Momenta Pharmaceuticals, Inc. MNTA 1.82% (before the market open)
• Paratek Pharmaceuticals Inc PRTK 2.23% (before the market open)
• Intercept Pharmaceuticals Inc ICPT 3.33% (before the market open)
• TG Therapeutics Inc common stock TGTX 0.96% (before the market open)
• Recro Pharma Inc REPH 7.06% (before the market open)
• Radius Health Inc RDUS 3.36% (before the market open)
• Voyager Therapeutics Inc VYGR 1.82% (before the market open)
• Chimerix Inc CMRX 5.57% (before the market open)
• Eagle Pharmaceuticals Inc EGRX 1.04% (before the market open)
• SAGE Therapeutics Inc SAGE 1.4% (before the market open)
• Neos Therapeutics Inc NEOS 0.14% (before the market open)
• Pieris Pharmaceuticals Inc PIRS 2.17% (before the market open)
• Protalix BioTherapeutics, Inc. PLX (before the market open)
• Intra-Cellular Therapies Inc ITCI 1.6% (before the market open)
• Biohaven Pharmaceutical Holding Co Ltd BHVN 6.82% (before the market open)
• Axsome Therapeutics Inc AXSM 0.04% (before the market open)
• Amicus Therapeutics, Inc. FOLD 0.39% (before the market open)
• Apyx Medical Corp APYX 0.4% (before the market open)
• Avadel Pharmaceuticals PLC AVDL 1.42% (before the market open)
• Akebia Therapeutics Inc AKBA 0.72% (before the market open)
• AcelRx Pharmaceuticals Inc ACRX 12.82% (after the market close)
• Athersys Inc ATHX 0.77% (after the market close)
• Adverum Biotechnologies Inc ADVM 3.77% (after the market close)
• Adaptive Biotechnologies Corp ADPT 4.66% (after the market close)
• Clearside Biomedical Inc CLSD 1.68% (after the market close)
• Pulse Biosciences Inc PLSE 3.25% (after the market close)
• Calithera Biosciences Inc CALA 9.89% (after the market close)
• Castle Biosciences Inc CSTL 0.36% (after the market close)
• Matinas BioPharma Holdings Inc MTNB 4.41% (after the market close)
• Catabasis Pharmaceuticals Inc CATB 0.93% (after the market close)
• CASI Pharmaceuticals Inc CASI 0.53% (after the market close)
• Celcuity Inc CELC 5.34% (after the market close)
• CorMedix Inc. CRMD 6.39% (after the market close)
• Integra Lifesciences Holdings Corp IART 0.59% (after the market close)
• Cara Therapeutics Inc CARA 0.18% (after the market close)
• Inovio Pharmaceuticals Inc INO 0.54% (after the market close)
• Precigen Inc NASDAQ: (PGEN) (after the market close)
• Rockwell Medical Inc (NASDAQ: RMTI) (after the market close)
• Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) (after the market close)
• ICU Medical Inc (NASDAQ: ICUI) (after the market close)
• Plus Therapeutics Inc (NASDAQ: PSTV) (after the market close)
• Liquidia Technologies Inc (NASDAQ: LQDA) (after the market close)
• Novavax
• Wave Life Sciences Ltd (NASDAQ: WVE) (after the market close)
• Urogen Pharma Ltd (NASDAQ: URGN) (after the market close)
• CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the market close)
• ChemoCentryx Inc (NASDAQ: CCXI) (after the market close)
• Chiasma Inc (NASDAQ: CHMA) (after the market close)
• Organogenesis Holdings Inc (NASDAQ: ORGO) (after the market close)
• Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the market close)
• Esperion Therapeutics Inc (NASDAQ: ESPR) (after the market close)
• Evolus Inc (NASDAQ: EOLS) (after the market close)

Tuesday

• BioNTech SE – ADR (NASDAQ: BNTX) (before the market open)
• STRATA Skin Sciences Inc (NASDAQ: SSKN) (before the market open)
• Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open)
• Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (before the market open)
• Affimed NV (NASDAQ: AFMD) (before the market open)
• Burning Rock Biotech Ltd (NASDAQ: BNR) (before the market open)
• Gamida Cell Ltd (NASDAQ: GMDA) (before the market open)
• 10X Genomics Inc (NASDAQ: TXG) (after the market close)
• Agile Therapeutics Inc (NASDAQ: AGRX) (after the market close)
• Aethlon Medical, Inc. (NASDAQ: AEMD) (after the market close)
• T2 Biosystems Inc (NASDAQ: TTOO) (after the market close)
• Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the market close)
• DiaMedica Therapeutics Inc (NASDAQ: DMAC) (after the market close)
• HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the market close)
• Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) (after the market close)
• Shockwave Medical Inc (NASDAQ: SWAV) (after the market close)
• RA Medical Systems Inc (NYSE: RMED) (after the market close)
• Inari Medical Inc (NASDAQ: NARI) (after the market close)

Wednesday

• Royalty Pharma plc (NASDAQ: RPRX) (before the market open)
• Altimmune Inc (NASDAQ: ALT) (before the market open)
• TELA Bio Inc (NASDAQ: TELA) (after the market close)
• Brickell Biotech Inc (NASDAQ: BBI) (after the market close)
• Dare Bioscience Inc (NASDAQ: DARE) (after the market close)
• Biocept Inc (NASDAQ: BIOC) (after the market close)
• ImmuCell Corporation (NASDAQ: ICCC) (after the market close)
• Eyenovia Inc (NASDAQ: EYEN) (after the market close)
• Eton Pharmaceuticals Inc ETON 1.78% (after the market close)
• Thermogenesis Holdings Inc (NASDAQ: THMO) (after the market close)
• OpGen Inc (NASDAQ: OPGN) (after the market close)
• KemPharm Inc (OTC: KMPH) (after the market close)
• Neoleukin Therapeutics Inc (NASDAQ: NLTX) (after the market close)
• Salarius Pharmaceuticals Inc (NASDAQ: SLRX) (after the market close)

Thursday

• Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open)
• PDS Biotechnology Corp (NASDAQ: PDSB) (before the market open)
• Zai Lab Ltd (NASDAQ: ZLAB) (before the market open)
• Veru Inc (NASDAQ: VERU) (before the market open)
• aTyr Pharma Inc (NASDAQ: LIFE) (after the market close)
• Caladrius Biosciences Inc (NASDAQ: CLBS) (after the market close)
• Dyadic International, Inc. (NASDAQ: DYAI) (after the market close)
• Myriad Genetics, Inc. (NASDAQ: MYGN) (after the market close)
• Histogen Inc (NASDAQ: HSTO) (after the market close)
• Lumos Pharma Inc (NASDAQ: LUMO) (after the market close)
• Viveve Medical Inc (NASDAQ: VIVE) (after the market close)
• Urovant Sciences Ltd (NASDAQ: UROV) (after the market close)

Friday

• PLx Pharma Inc (NASDAQ: PLXP) (before the market open)
• Ocugen Inc (NASDAQ: OCGN) (before the market open)

IPO Quiet Period Expiry

Relay Therapeutics Inc (NASDAQ: RLAY)
Pandion Therapeutics Inc (NASDAQ: PAND)
ALX Oncology Holdings Inc (NASDAQ: ALXO)
Renalytix AI PLC (NASDAQ: RNLX)
https://www.benzinga.com/general/biotech/20/08/16993967/the-week-ahead-in-biotech-bausch-health-fennec-pharma-fda-decisions-and-smid-cap-earnings

US rescinds global ‘do not travel’ coronavirus warning

The Trump administration on Thursday rescinded its warnings to Americans against all international travel because of the coronavirus pandemic, saying conditions no longer warrant a blanket worldwide alert.

The State Department lifted its level-four health advisory for the entire world in order to return to country-specific warnings. That move came shortly after the Centers for Disease Control and Prevention revised its COVID-19 travel advisory information. The CDC lifted “do not travel” warnings for about 20 locations but advised staying away from the vast majority of the world.

“With health and safety conditions improving in some countries and potentially deteriorating in others, the department is returning to our previous system of country-specific levels of travel advice in order to give travelers detailed and actionable information to make informed travel decisions,” the State Department said in a statement.

“This will also provide U.S. citizens more detailed information about the current status in each country,” it said. “We continue to recommend U.S. citizens exercise caution when traveling abroad due to the unpredictable nature of the pandemic.”

The State Department invoked the blanket warning against all international travel on March 19 as the pandemic spread. The revised country-specific travel advice is available at travel.state.gov. However, Americans still face travel restrictions across the world because of the uncontrolled spread of the coronavirus in the country.

Earlier Thursday, the CDC revised its travel guidance, saying the changes were driven by how the virus was spreading in different places and how well the public health and health care systems were functioning in dealing with new cases.

Seven places, including Thailand, Fiji and New Zealand, are in a low-risk group, according to the CDC, although officials there advised that certain people, such as older adults and those with certain underlying medical conditions, talk to their doctors before making the trip. For more than a dozen other locations, it had no precautions. Taiwan, Greenland, and Laos are on that list.

But the CDC continues to advise against nonessential travel to more than 200 other international locations.

https://medicalxpress.com/news/2020-08-rescinds-global-coronavirus.html