- Industry Voices—As COVID-19 flare-ups continue, healthcare organizations must double down on drug diversion (fiercehealthcare.com)THE CONSEQUENCES OF COVID-19 ON THE OVERDOSEEPIDEMIC: OVERDOSESAREINCREASING (files.constantcontact.com)
Yet, while we’re hyper-focused fighting COVID-19, our country’s opioid epidemic is growing worse...A report released...suggests that overdose deaths have increased due to COVID-19. The Washington Post reported that suspected overdoses jumped 18% in March, 29% in April and 42% in May. The figures are based on data from ambulance teams, hospitals and police...What’s not being reported is the potential threat of drug diversion within healthcare settings, which is often undetected and underreported...Given the social, economic and healthcare implications of COVID-19, it’s not hard to see how drug diversion might escalate...data suggest a rise in depression and mental health disorders with the coronavirus stemming from isolation, "shelter at home" guidelines and the economic fallout of the pandemic. Healthcare providers, who are more likely to treat patients with COVID-19, may be more susceptible to mental health issues such as depression and burnout...READ MORE
- HHS allocates $1.4B to children’s hospitals affected by COVID-19 (fiercehealthcare.com)
The Trump administration released $1.4 billion to almost 80 children’s hospitals that have been impacted by the COVID-19 pandemic...The money comes out of a $175 billion fund Congress passed a few months ago to help providers that have been slammed by a financial crisis caused by the COVID-19 pandemic...“Children’s hospitals have seen decreasing patient visits and increased costs,” the Department of Health and Human Services said...“This distribution will help to ensure children’s hospitals receive relief funding proportional to other hospitals across the nation and providers caring for children are able to continue operating safely in some of our most vulnerable communities.”...HHS already gave out nearly $15 billion to safety hospitals and $11 billion to rural healthcare providers. The agency is also allocating funding to hospitals that have seen a high number of COVID-19 cases...READ MORE
- Trevena preps low-key launch, responsible marketing for long-awaited opioid Olinvyk (fiercepharma.com)
Trevena notched its first drug approval...with intravenous opioid Olinvyk. Now comes the tricky part—navigating the politics of marketing a new opioid product...To do that, Trevena plans to take a narrowly focused approach, targeting healthcare professionals in acute care settings with a focus on complex patient types including elderly, obese and renally impaired people...Sales rep training, compliance and monitoring programs are also in place to ensure marketing sticks to FDA guidelines. Trevena will look to use a range of digital, virtual, on-demand and in-person channels to reach HCPs...READ MORE
- New Jersey medical office sues Cigna over denied COVID-19 testing, treatment claims (fiercehealthcare.com)
A New Jersey medical office has filed suit against Cigna, alleging that the insurer failed to pay for diagnostic testing and treatment related to COVID-19 in violation of the CARES Act...Open MRI and Imaging of RP Vestibular Diagnostics claims that Cigna owes it nearly $400,000 in unpaid claims for care related to the novel coronavirus, and that the decisions to decline coverage were "arbitrary."..."The explanations given by [Cigna] for its refusal to make payment include unelaborated denials that the services were rendered as billed, or matched the services billed, as well as the occasional contention that the billing was duplicative," according to the lawsuit. "The grounds for rejecting plaintiff's claims were, upon information and belief, false and invalid."...READ MORE
- EPA approves a virus-killing coating for American Airlines, studies use by schools (reuters.com)Dallas company touts its spray-on coating as a COVID-19 killer for surfaces (dallasnews.com)
The U.S. Environmental Protection Agency said...it has granted emergency approval for American Airlines to use a disinfectant against the coronavirus on certain surfaces that lasts for up to seven days, and is studying whether it could be effective in places like schools...EPA Administrator Andrew Wheeler said at a news briefing that SurfaceWise2, made by Allied BioScience Inc, is the first long-lasting product approved by the agency to help fight the spread of the novel coronavirus...American Airlines will begin spraying its airplane cabins with the disinfectant in its home base of Texas after the state filed the request for emergency approval. The carrier hopes to eventually use it across its entire fleet, including its American Eagle regional partners...READ MORE
- PNG demands China explain COVID-19 vaccine trial on miners (apnews.com)
Papua New Guinea blocked the arrival of a flight carrying workers from China after a Chinese mine operator said its employees were given a coronavirus vaccine in a possible unauthorized trial…The Pacific nation’s pandemic response controller, David Manning, banned COVID-19 vaccine trials after Ramu NiCo Management Ltd. said it vaccinated Chinese employees… Manning said he ordered a flight carrying 180 Chinese workers turned back…as a precaution. He said he acted “in the best interests of our people” because of “possible risks or threat that it might cause.”… Manning said the National Department of Health had not approved any trials. He said any vaccines required approval by the World Health Organization and had to undergo “vigorous vaccine trials, protocols and procedures.”…READ MORE
- McKesson signs up with Warp Speed to distribute COVID-19 shots in U.S. (fiercepharma.com)
The U.S. government has placed a series of multibillion-dollar bets on potential COVID-19 vaccines. But actually getting those vaccines to patients is another story, and now the government has picked a distributor to aid that effort...The Trump administration has tapped Dallas-based distribution giant McKesson to partner with the Centers for Disease Control and Prevention as a national distributor for COVID-19 vaccines...Under a 2016 childhood vaccine deal, the CDC had an option to draft McKesson to distribute vaccines in case of a pandemic, according to a Department of Defense...McKesson's Warp Speed pact comes as the Trump administration looks to flesh out a production and distribution framework for one or more approved vaccines by the end of the year...READ MORE
- FDA Authorizes Use of Blood Plasma to Treat Coronavirus (newsmax.com)UN cautions that virus plasma treatment still experimental (apnews.com)FDA's emergency nod for convalescent plasma sparks questions of whether it's bowing to Trump (fiercepharma.com)
The U.S. Food & Drug Administration...said it authorized the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the disease...The FDA...said early evidence suggests blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization..."It appeared that the product is safe and we're comfortable with that and we continue to see no concerning safety signals," said Peter Marks, director of the Food and Drug Administration's Center for Biologics Evaluation and Research...The agency also said it determined this was a safe approach in an analysis of 20,000 patients who received this treatment...Patients who benefited the most from this treatment are those under 80 years old and who were not on a respirator, the agency said. Such patients had a 35 percent better survival rate a month after receiving the treatment...READ MORE
- Drug payment cuts to 340B hospitals spur debate on best path forward (healthcarefinancenews.com)
Hospitals say revenue from the 340B program is essential, while others contend the original law is being abused...an federal appeals court ruled that 340B hospitals will now be subject to Medicare cuts in outpatient drug payments by nearly 30%... gives...the Department of Health and Human Services the legal authority to reduce payment for Medicare Part B drugs to 340B hospitals...the action means patients – particularly those who live in vulnerable areas – will pay less out-of-pocket for drugs in the Medicare Part B program...providers...said the 340B decision will hurt hospitals and patients in these vulnerable areas...Hospitals that serve large numbers of Medicaid, Medicare and uninsured patients were getting the drugs for a discounted price, but, getting reimbursed at the higher price...The hospitals...are in the red or operating on thin margins, were using the pay gap in the price difference to cover operational expenses. HHS deemed it inappropriate that these facilities would use Medicare to subsidize other activities and initiatives...READ MORE
- FDA flags accuracy issue with widely used coronavirus test (apnews.com)
Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned...The Food and Drug Administration issued the alert...to doctors and laboratory technicians using Thermo Fisher’s TaqPath genetic test. Regulators said issues related to laboratory equipment and software used to run the test could lead to inaccuracies. The agency advised technicians to follow updated instructions and software developed by the company to ensure accurate results...Dr. Albert Ko of Yale’s School of Public Health said the potential accuracy problems have “pretty serious implications” given that Thermo Fisher’s test is used widely both in the U.S. and around the world to screen for coronavirus...The FDA has used its emergency powers to OK more than 200 tests for coronavirus since February. No test is perfect and all are expected to give at least a small percentage of false negatives and false positives...READ MORE










