New Mexico Poised to Add the ‘Data Breach Notification Act’ to the Patchwork of State-Level Data Privacy Laws

The New Mexico Legislature passed the ‘Data Breach Notification Act’ (the Act) on March 15. The Act is now with Governor Susana Martinez who has 20 days from the date the Act was passed to sign it into law. If enacted, the Act would require a person, other than a […]

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

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 […]

The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB Act) by a vote of 240 to 185, split mostly along party lines. If passed by the U.S. Senate and signed by President Trump, the SCRUB Act would […]

Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain […]

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 […]