With the deadline for the reauthorization of the Medical Device User Fee Amendments (MDUFA) looming in September, many observers expect that the push for reform in the regulation of in vitro diagnostic (IVD) tests may soon be coming to a head on Capitol Hill. At its core, the debate boils down to whether regulatory oversight [...] Read More
Here are some reimbursement related reasons why access to biosimilars has been slower than hoped, even though patient out-of-pocket costs are lower. Current System Is an Improvement Over Earlier System, But Could Be Better Part B Is For Biologics (and Some Drugs) When I was working at the Senate Legislative Counsel’s office drafting the Average [...] Read More
Every year, thousands of Americans hear the devastating news that they have Alzheimer’s disease. This diagnosis carries with it a certain future of declining mental and behavioral capabilities, and the eventual need for round-the-clock end-of-life care. The financial costs can be staggering, and the emotional costs immeasurable. While the impact of Alzheimer’s can be slowed, […]
Read MoreThe Centers for Medicare & Medicaid Services (CMS) has released its much-anticipated Calendar Year (CY) 2018 Quality Payment Program (QPP) Final Rule. In this final rule, CMS details changes to both the Advanced Alternative Payment Models (APMs) track and the Merit-Based Incentives Payment System (MIPS) track of the QPP. CMS says it expects this program to, “Modernize […]
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