• Georgia: CDC announced that six more people have died have consuming products contaminated with listeria. In July, CDC said it was investigating a nationwide outbreak of listeria, which was linked to sliced deli meats. So far, a total of 57 people have been hospitalized, and nine have died. According to the New York Times, this is the largest outbreak of listeriosis since 2011 when at least 13 people in eight states died after eating contaminated cantaloupe. Since the outbreak, Boar's Head has recalled millions of pounds of meat, which were manufactured at the company's plant in Jarratt, Virginia. The recall includes around 70 products and mostly affects those that are sliced at deli counters. Currently, CDC is warning consumers not to eat any of the recalled products. Health officials are also asking people to check their fridges for any recalled products, which include EST. 12612 or P-12612 inside the U.S Department of Agriculture mark of inspection on the product label. (Fortinsky, The Hill, 8/29; Moses, New York Times, 8/28)
• Maryland: CMS has finalized a rule to ease reimbursement for medical device makers. The program, which is called Transitional Coverage for Emerging Technologies (TCET), gives device makers that have products deemed "breakthrough" technology by FDA a faster way to gain Medicare coverage. Under the rule, CMS committed to offer a coverage decision six months after FDA authorization. According to the agency, it expects to accept five device makers a year into the program. However, some device makers have expressed concerns that the rule excludes diagnostics. "The final TCET notice is a step toward a stronger, more robust policy, but doesn't go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering," said Scott Whitaker, CEO of AdvaMed. "The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS." (Lawrence, STAT+ [subscription required], 8/7)
• Maryland: FDA has approved Gilead Sciences' drug, Livdelzi, to treat primary biliary cholangitis (PBC), an autoimmune liver disease. Originally, Livdelzi was developed by Cyma Bay Therapeutics, which was acquired by Gilead for $4.3 billion earlier this year. Gilead estimates there are approximately 130,000 people with PBC in the United States, and around 30,000 to 40,000 of these patients don't respond to first-line therapy. According to STAT+, competition will come from Ipsen's Iqirvo, which was approved by FDA in June, and an older medication called Ocaliva. "There's still a real need out there for patients with PBC today, despite all the new arrivals," said Johanna Mercier, Gilead's chief commercial officer. "We believe Livdelzi can make a real difference for these people." Livdelzi will cost $12,606 for a 30-day supply, or $151,272 per year, before any insurance discounts or rebates, Gilead said. (Feuerstein, STAT+ [subscription required], 8/14)

Americans eat a lot of sandwiches, which can often be loaded with sodium, saturated fats, added sugars, and preservatives. But experts say there are changes you can make to your sandwiches to improve your health, Andrea Petersen reports for the Wall Street Journal.