Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT). First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs. This guidance marked a significant shift in the regulation of LDT as FDA has chosen […]
On Friday, October 14th, the Center for Medicare & Medicaid Services (CMS) released the long-anticipated final rule with 60-day comment period (Rule) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program (QPP). The QPP provides incentive payments for participation in Advanced Alternative Payment Models (Advanced APM). […]
As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors. Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as […]
Last week, Vermont adopted the first state law that requires drug companies registering the highest hike in prices to justify the rationale for the increase. Vermont policymakers are not alone pursuing laws that address rising drug prices. California and Ohio are eyeing pricing-related bills and ballot initiatives. This begs the question: If […]
Health care policy issues continue to stream out of Congress and the Administration. The Senate held a markup of various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.
Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates. Moreover, proposals directed at addressing the […]
Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices. From the letter, the rationale for selecting these companies is that together they “control more […]