Articles by Michael B. Glomb

Attorneys from FTLF’s health care practice group will be presenting at educational sessions during the 2016 NACHC Policy & Issues (P & I) Forum from March 16-19, 2016 in Washington, D.C. The forum will address various topics, such as the 340B Drug Pricing Program, HRSA Operational Site Visits, State Payment…

Attorneys from FTLF’s health care practice group will be presenting at educational sessions during the 2016 340B Coalition Winter Conference in San Diego, California. The 340B Coalition Winter Conference will address various topics, such as key areas of HRSA’s proposed mega-guidance and the potential impact on 340B stakeholders, key legislative…

On Tuesday, October 6, 2015, the OIG released a Policy Reminder reminding the public about how information blocking may affect safe harbor protection under the Federal anti-kickback statute.  OIG extends safe harbor protection to certain arrangements involving donations of interoperable EHR items and services to potential referral sources.  However, if…

On August 28, 2015, the Health Resources and Services Administration (HRSA), which administers 340B Drug Pricing Program, released long-awaited proposed guidance (“Guidance”). The purpose of the Guidance is to assist 340B covered entities and drug manufacturers in complying with the statutory requirements of the 340B Program. In its current form,…

Today the Health Resources and Services Administration (HRSA) released guidance for covered entities enrolled in the 340B Drug Pricing Program (340B Program) and for drug manufacturers that participate in the 340B Program. The purpose of the guidance is to assist 340B covered entities and drug manufacturers in complying with the…