Tag: Congress

Drug Pricing 2019 Year in Review

In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while spending months on an array of legislation, did not manage to send anything major to the […]

Administration releases drug importation plan but implementation questions abound

Today, the Department of Health and Human Services (HHS) announced two “pathways” for drug importation. This plan is the latest step in the Administration’s push to lower prescription drug prices and one the President has strongly supported.   However, implementation of this plan has a long time horizon and a very […]

No Surprise! – Drug Pricing Legislation Picking up Steam

Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress. On Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the bipartisan Lower Health Care Costs Act (LHCCA) discussion draft. Today, the Committee released a new draft based on […]

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 […]

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

***Further update – Federal Court Vacates Rule*** Yesterday, U.S. District Court for the D.C. Circuit Judge Amit Mehta invalidated the final rule.  In ruling on the merits, Judge Mehta said the Department of Health and Human Services went beyond its rulemaking authority.   Specifically the ruling states, “[n]either the Act’s text, structure, […]

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 […]