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Drug manufacturers have had little choice but to act on their own to identify and mitigate the impact of duplicate 340B discounts...Marcy Imada...director at Deloitte & Touche LLP... said preventing duplicate 340B discounts “has proven to be a challenging and long-standing problem for the industry, and in particular for manufacturers. There have been numerous government studies and recommendations provided over the years to try to address this duplicate discounts challenge.”...manufacturers have been left with little choice but to take “more proactive steps” and implement “new strategic initiatives,”... “At least a couple of manufacturers have communicated plans to limit sales at 340B discounted prices billed to a covered entity and shipped to 340B contract pharmacies,” she said...READ MORE

A Food and Drug Administration advisory panel recommended Thursday that Moderna Inc.’s MRNA 5.09% Covid-19 vaccine be cleared for broad use, setting the stage for the FDA to grant an expected emergency-use authorization by late Friday...The advisory panel’s vote was 20-0, with one abstention, to recommend use of the Moderna vaccine for people 18 years of age and older. That puts it in line to become the second Covid-19 vaccine to be granted an emergency use authorization, following the FDA’s green light of a vaccine from Pfizer Inc. and BioNTech SE last week...READ MORE

Britain has agreed to spend 3.7 billion pounds ($4.93 billion) on COVID-19 vaccines and in most cases will bear the liability if claims are made against the pharmaceutical firms involved...The government has agreed supply deals for 357 million doses of seven different candidate shots, but has not gone into detail about how much it has spent or indemnity agreements, citing commercial confidentiality around the contracts...READ MORE

The Department of Health and Human Services finalized a long-awaited rule that sets up a process to resolve disputes surrounding the controversial 340B drug discount program...The final rule...comes as several drugmakers have restricted access to drugs discounted under the program. The rule could weigh in on the center of the feud: contract pharmacies...The process will resolve claims by safety net hospitals and other entities in the 340B program that a drug company overcharged them. It also allows drug companies to appeal if a covered entity violated a part of the program such as getting duplicative discounts...READ MORE

The Food and Drug Administration is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began to be administered this week...Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the reactions had been reported in more than one state besides Alaska and that the FDA is probing five reactions...“We are working hand in hand with the Centers for Disease Control and Prevention (CDC), and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said...READ MORE

The U.S. Centers for Medicare and Medicaid Services issued a proposed rule Thursday aimed at improving the electronic exchange of healthcare data among payers, providers and patients...The rule would require Medicaid, CHIP and QHP programs to build HL7 FHIR-based APIs to support data exchange and prior authorization. It also includes a proposed API standard for healthcare operations nationwide...The proposed rule seeks to enhance the patient access API by requiring the use of specific HL7 implementation guides by impacted payers...READ MORE

The first shipments of COVID-19 vaccine left on trucks and planes early on Sunday, kicking off a historic effort to stop a surging pandemic that is claiming more than 2,400 lives a day in the United States...Mask-wearing workers at a Pfizer Inc factory in Michigan began packing the first shipments of the vaccine developed with German partner BioNTech SE in dry ice shortly after 6:30 a.m. ET (1130 GMT) on Sunday...Trucks carrying pallets of boxed, refrigerated vaccine began rolling away from the Kalamazoo facility, escorted by body armor-clad security officers. The shots then were loaded onto FedEx and United Parcel Service planes that will whisk the precious cargo across the country...“Today, we’re not hauling freight, we’re delivering hope,”...READ MORE

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older...READ MORE

Prime Minister Justin Trudeau said Tuesday that Canada has contracted to receive up to 168,000 doses of the Moderna COVID-19 vaccine before the end of December, pending approval by the country’s health regulator...Canadians began receiving vaccine shots developed by Pfizer and BioNTech on Monday and Trudeau said Canada expects to receive about 200,000 doses from Pfizer next week. Canada received an initial batch of 30,000 this week...READ MORE

The Trump administration proposed changes...to data privacy rules to give patients more access to their health information and improve care coordination...The changes to the Health Insurance Portability and Accountability Act Privacy Rule will support patients' engagement in their care, remove barriers to coordinated care and reduce regulatory burdens on the healthcare industry, the Department of Health and Human Services...READ MORE