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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 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

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

This past week Minnesota became the second state to reject regulations that effectively ban the controversial drug hydroxychloroquine for use by COVID-19 patients...The decision, which comes two weeks after the Ohio Board of Pharmacy reversed an effective ban of its own, was rightfully praised by local health care advocates...The reversal by (Gov Tim Walz) Walz, a first-term Democrat, clears the way for doctors to prescribe hydroxychloroquine, a drug commonly used to treat malaria and other conditions but one the FDA has declined to recommend for COVID-19 treatment...The politics of hydroxychloroquine are unlikely to cool before November’s presidential election. Yet, if Walz’s decision is any indication, at least some leaders are starting to recognize the ethical dilemma of using the long arm of government to stand between suffering patients and a drug that may have the potential to save them...READ MORE

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

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

The U.S. Department of Justice has been hot on the heels of some of pharma's biggest players in a yearslong probe into an alleged industrywide co-pay kickback scheme...Federal prosecutors accused Teva in a new lawsuit of paying kickbacks to two patient copay assistance charities as part of a scheme to pump up prescriptions of multiple sclerosis med Copaxone...The filing in a Boston district courthouse alleged the company paid more than $300 million to those third-party organizations and defrauded Medicare of "hundreds of millions" in reimbursements...READ MORE

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

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

Hospitals and health systems are building a major presence in the specialty pharmacy industry...nine out of ten large hospitals now operate a specialty pharmacy. Hospitals and other healthcare providers account for one-third of all U.S. accredited specialty pharmacies...Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth. The enormous profit opportunities from the 340B Drug Pricing Program offer further encouragement for hospitals. In-house specialty pharmacies are also a valuable hedge against the potential loss of contract pharmacies...READ MORE