Category: The Affordable Care Act

FDA Issues First of Four Draft Guidances Related to Patient-Focused Drug Development

Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1), to address how stakeholders can collect and submit patient experience data from patients, caregivers, clinicians and patient advocacy groups for product development and regulatory decision-making. “Patient experience data” is defined as data that is “collected by […]

**UPDATED*** Administration Releases Long-Awaited Drug Pricing Reform Plan

***5/14/2018 Update***   This morning, HHS Secretary Azar gave a speech offering additional details on the Blueprint.  Included in his remarks are plans to publicly identify companies suspected of “using public health rules to pad their profits”; send letters to all Medicare Part D plan sponsors indicating gag clauses in pharmacy contracts are unacceptable […]

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 […]

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 […]

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 […]

Off to the Races: First ACA Repeal and Replace Legislation Released

Following through on Republican campaign promises, two key Congressional committees released legislation yesterday that further the process of repealing and replacing the Affordable Care Act (ACA).  After more than 60 attempts to repeal the ACA since 2010, GOP members of the  House Energy and Commerce and Ways and Means Committees released details […]

Price Confirmed for HHS Secretary, other key agency and department positions next to be filled

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services.  The vote was 52-47 with no Democrats voting in favor.  With repeated attacks on his policy record and questions about stock purchases, Price’s nomination was […]