Tag: Congress

Medicare for All unveiled in House. Some things old, some things new, but much left to do

Recently, progressive democrats in the House of Representatives lead by Rep. Pramila Jayapal (D-WA) and Debbie Dingell (D-MI) released the long-awaited Medicare for All Act of 2019 (M4A) proposal.  M4A differs from single-payer plans released by Senator Bernie Sanders (I-VT) and various Washington think tanks. One of the most significant differences […]

HHS Releases Plan to Require Drug Makers to list prices on TV ads

Yesterday, the Department of Health and Human Services (“HHS”) through the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would require “direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition […]

White House Declares Opioid “Public Health Emergency” However, Many Questions Remain

Last week, the White House declared the opioid crisis a “public health emergency.” The declaration outlined a number of steps the Administration will take to address the epidemic. The public health emergency declaration, while acknowledging the scope and tragic costs of opioid abuse, falls short of a “national emergency” declaration […]

With Congress stuck, Administration starts process of unwinding ACA – Updated

Last week, the Administration took two actions aimed at rattling the foundations of the Affordable Care Act (ACA).  The President signed an Executive Order (EO) directing federal agencies to relax restrictions on insurance plans that do not have to comply with certain ACA rules.  The Administration followed that with an announcement […]

CMS Withdraws Part B Demo Rule…for good

Earlier today, the Centers for Medicaid Services (CMS) released a notice withdrawing the “Medicare Program; Part B Drug Payment Model”, also known as the “Part B Demo.”  As we discussed in a previous post, in December 2016, the Obama Administration announced it would not move forward with the program.  This, coupled with […]

Off-Label Use Gets Congressional Hearing

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug Administration (FDA) can provide clarity for drug and device companies regarding dissemination of truthful and non-misleading data […]

User Fee Reauthorization Picks Up Steam

In preparation for a vote this week, the House of Representatives Committee on Energy and Commerce yesterday released a new draft of the user fee reauthorization.  The bill, titled the “FDA Reauthorization Act of 2017,” contains several new sections to align with user fee legislation passed by the Senate in […]