Category: Healthcare

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 […]

OIG and HCCA Release Compliance Program Effectiveness Resource Guide

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide (Guide). The Guide is the joint work product of a group of 40 compliance professionals and OIG staff […]

Compliance Date for Drug Supply Chain Security Act Serialization and Verification Requirements Quickly Approaching

Manufacturers must begin to comply with the Drug Supply Chain Security Act (DSCSA) serialization and verification requirements on November 27, 2017 (Compliance Date). Serialization and verification are intended to enable entities in the drug supply chain to exchange information about products at the package level. Product identifiers, including Standardized Numerical […]

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 […]

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 […]