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
On September 17, 2018, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.” The proposed rule was developed in response to President Trump’s executive order that instructed agencies to look for ways to reduce regulatory burden. The agency also notes that [...] Read More
On Thursday, September 6 and Friday, September 7, 2018, the Medicare Payment Advisory Commission (MedPAC) met for its first public meeting of the 2018-2019 cycle. The meeting began with a presentation on the “Context for Medicare payment policy,” intended to orient Commissioners and set the scene for upcoming chapters. The presentation outlined existing and projected [...] 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 MoreOn December 27, CMS issued a State Medicaid Director letter to explain new limitations on federal financial participation for durable medical equipment (DME) in Medicaid. Beginning on January 1, 2018 (as required by Section 5002 of the 21st Century Cures Act), federal reimbursement to states for DME expenditures in Medicaid will be limited to the […]
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 […]
Read MoreIn what is likely the first major Medicare policy change of the Trump Administration, Medicare payment for 340B drugs administered in the hospital outpatient department will be cut from 106% of average sales price (ASP, or ASP+6%) to average sales price less 22% (ASP-22%). Those who have been following President Trump’s statements on health care […]
Read MoreThis evening, CMS also released the CY 2018 Home Health Prospective Payment System (HH PPS) Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements final rule which will be effective on January 1, 2018. Within this rule, CMS announces an overall payment adjustment of -0.4 […]
Read MoreOn Wednesday, August 2, 2017, the Centers for Medicare & Medicaid Services (CMS) issued its final Inpatient Prospective Payment System (IPPS) rule for Fiscal Year 2018. The rule outlines how hospitals are paid for inpatient Medicare stays, starting October 1, 2017. This rule finalizes a number of changes proposed in the IPPS proposed rule issued in April, but does […]
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