Author: Peter

Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, testified...before the U.S. Senate...He noted that although a vaccine against COVID-19 will likely be available and to begin dosing in November or December of this year, it will be limited. Getting the entire U.S. population vaccinated will likely take “six to nine months.”...He also said that face masks are “the most important, powerful public health tool we have.” He added, “I might even go so far as to say that this face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine.”...READ MORE

Biosimilars, which offer the potential for more treatment options and less expensive alternatives, are having a good year in 2020 and may have a significant impact on the prescription product market in 2021. With the approval of more biosimilar medications, experts hope that greater competition may occur and help lower overall costs. “As intellectual property protections for biological products continue to expire in the US, we can expect many more applications for potential biosimilar and interchangeable products, and increased uptake of approved products too,”...Some of the key issues affecting biosimilar uptake involve reimbursement factors and insurance coverage...However...business and intellectual property concerns also have contributed to the delayed launch of some FDA-approved biosimilars. ...READ MORE

After touting a series of executive orders on drug pricing in late July, President Donald Trump has now unveiled the most significant among them—an order tying Medicare's drug prices to much lower costs in other developed countries. The biopharma industry pushed back hard, and it’s unclear exactly when or how the changes would be implemented...The executive order...says Medicare should not buy certain Part B or Part D drugs unless at prices paid by “at a minimum, the lowest price at which the manufacturer sells that drug to any other developed nation.” In Part D, the plan would apply “where insufficient competition exists” and where “seniors are faced with prices" higher than those in other developed nations...READ MORE

Nevada’s group health insurance program for state employees consistently failed to seek competitive bids on nearly $96 million worth of contracts over the past four fiscal years, according to a recent state audit that also found examples of “wasteful spending” and state policies not being followed...An audit report released last week by the Legislative Counsel Bureau’s Audit Division into the contract management practices of the Public Employees Benefits Program...found that leadership of the health insurance program consistently failed to follow state laws and policies requiring contracts be put out to bid every four years, choosing instead to extend contracts in violation of normal practices for state agencies...The audit also found PEBP management often privately negotiated contract extensions without putting them out to a competitive bid, including one instance where one under-performing vendor had a contract extended and scope expanded after PEBP staff took paid trips to their headquarters at an estimated cost of more than $7,000...READ MORE

Safe and effective vaccines represent the most effective way to restore the health and economic security disrupted by the Covid-19 pandemic. To help achieve that goal, the U.S. government launched Operation Warp Speed...to accelerate development and manufacturing of several Covid-19 vaccines, with a goal of having 300 million doses available to the U.S. population by January 2021...Operation Warp Speed is expediting vaccine development primarily by moving clinical trials forward without pauses between phases, and by scaling up manufacturing capacity before knowing if a candidate works...Covid-19 vaccines can help stop the pandemic only if people trust them and want to be vaccinated. To earn and keep the trust of the American people, our government needs to ensure three key needs are met before launching any immunization campaign...READ MORE

• Ensure transparency and confidence in FDA decisions
• Ensure robust active safety monitoring as Covid-19 vaccines are rolled out
• Ensure the distribution and administration of Covid-19 vaccines are equitable and well-executed

A panel of government health advisers said...there’s no clear evidence that a harder-to-crush version of the painkiller OxyContin designed to discourage abuse actually resulted in fewer overdoses or deaths...The conclusion from the Food and Drug Administration advisory panel comes more than a decade after Purdue Pharma revamped its blockbuster opioid, which has long been blamed for sparking a surge in painkiller abuse beginning in the 1990s...The long-acting OxyContin tablets can still be misused by simply swallowing them, which remains the most frequent route among those with opioid addiction...READ MORE

Safety net hospitals that participate in the 340B drug discount program generated $64.3 billion in total benefits to community programs and services tailored to help low-income patient populations, a new analysis finds...The analysis, published...from the American Hospital Association, comes as hospitals wage a war with drug companies that have begun restricting sales of discounted products to 340B contract pharmacies. AHA charges the 340B program enables safety net hospitals to help patients in vulnerable communities, but drug companies argue the program has gotten too large and hospitals are not helping patients with the savings...READ MORE

Hospital groups praised the Trump administration's decision Monday to pull a Medicaid rule aimed at fiscal accountability, which providers warned could lead to massive cuts in reimbursement..."up to $50 billion in annual funding for the Medicaid program was on the line" if the rule had been finalized..."We appreciate CMS for acknowledging the harmful consequences this rule would have for patients,"..."Hospitals and health systems will be greatly relieved when the proposed rule is formally withdrawn."...The Centers for Medicare & Medicaid Services first unveiled the Medicaid Fiscal Accountability Rule in November, with the goal of tamping down on schemes used by states to boost federal matching funds in the program...READ MORE

A federal program aimed at lowering Medicare costs by incentivizing providers to move from fee-for-service to value-based care models generated $1.2 billion in net savings to Medicare last year, the Centers for Medicare & Medicaid Services announced...CMS Administrator Seema Verma credited savings seen under the Medicare Shared Savings Program to recent rules that shortened the pathway for financial risk...These results are additional evidence that physician-led practices can be successful in generating savings through value-based care..."Once again, physician-led ACOs out-performed hospital ACOs,"..."What we need now is to help more practices participate in these models of care."...READ MORE

Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs?...California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week...FDA investigators found that Calvin Scott used suspect heat-sealed pouches to package its version of hydrochlorothiazide...Investigators also found Calvin Scott had inadequate cleaning procedures in place, which led to its drug products sharing multiple surfaces and potentially being cross-contaminated...READ MORE