Tag: Congress

With Congress stuck, Administration starts process of unwinding ACA

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 […]

House Passes AHCA; Senate Says “Not So Fast”

Last week, the House of Representatives passed the American Health Care Act (AHCA) by a razor-thin margin of 217-213. No Democrats supported the bill and 20 Republicans voted against it. Recall in March, the House was forced to pull AHCA Version 1.0 from the floor because leaders lacked the necessary […]

User Fee Act Legislation Introduced Free of Controversial Issues…for the Time Being

Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs. The legislation reauthorizes fees for pharmaceuticals, generics, biosimilar and medical devices through 2022.  A section –by–section […]

CBO Releases AHCA Budget Score; As Costs Become Clearer, Road to Passage Gets Rockier

Yesterday, the Congressional Budget Office (CBO) released the budget “score” or cost, for the American Health Care Act (AHCA). The headline from the analysis is that the AHCA would cause 14 million people to lose health care coverage.  Notwithstanding passage by the House Energy and Commerce and Ways and Means committees last week, the […]