A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
Medicare coverage of ventricular assist devices assumes the patient is either in end-stage heart failure or could become a candidate for transplant, but that approach may soon change. Abbott Laboratories, of Abbott Park, Ill., has asked that Medicare coverage assume the patient can recover myocardial function, a paradigm shift that is backed by clinical evidence.
Touting the efforts his administration already has taken to lower U.S. prescription drug prices through increased competition, President Donald Trump placed the burden for further action squarely on Congress during his State of the Union address Tuesday, Feb. 4.
Now that U.S. Health and Human Services (HHS) Secretary Alex Azar has declared a nationwide public health emergency due to the 2019 novel coronavirus (2019-nCoV), HHS is saying it may need more money to help it be as proactive and aggressive as possible in detecting the virus and containing an outbreak.
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
Syncardia Systems LLC, of Tucson, Ariz., has petitioned the Centers for Medicare and Medicaid Services (CMS) to drop the coverage with evidence development (CED) mandate for artificial hearts, stating that multiple studies have demonstrated that artificial hearts meet the reasonable and necessary standard. Syncardia said its temporary Total Artificial Heart (TAH-t) should thus be available “unencumbered by the existing requirement for evidence development,” a change that could modestly bolster utilization and sales of these devices.
Zimmer Biomet Holdings Inc., of Warsaw, Ind., reported good news for the fourth quarter, which saw net sales of $2.126 billion, an increase of 2.6% over the prior year period. In terms of geography, the Americas and Asia-Pacific stood out. In addition, the company witnessed strong results globally in its knee and hip businesses.
The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.
Heartflow Inc., of Redwood City, Calif., is working on two Medicare administrative contractors (MACs) to cover its functional flow reserve algorithm for the coronary arteries, but Heartflow’s Heather Brown told BioWorld that said that the existing local coverage policies fall far short of the cost of the service, thus impeding beneficiary access.
Edwards Lifesciences Corp., of Irvine, Calif., reported positive quarterly results Jan. 30, and it was particularly bolstered by strength with transcatheter aortic valve replacement (TAVR). CEO Mike Mussallem called out the fourth quarter underlying sales growth of 19%, giving much credit to TAVR.
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