Health Law Alert

For years, we have been tracking the Department of Labor’s Office of Federal Contract Compliance Programs’ (“OFCCP”) efforts to expand its jurisdiction to health care employers.  Generally, the OFCCP enforces regulations that require employers with at least 50 employees, who hold a single contract or subcontract of at least $50,000 […]

On August 15th, the Office of Inspector General (OIG) released a report sure to add fuel to the continuing debate over Medicare payments to rural providers: “Most Critical Access Hospitals Would Not Meet the Location Requirements if Required to Reenroll in Medicare.” After digitally plotting critical access hospital (CAH) and […]

Health care providers and suppliers are well aware that they are living in a world of increased enforcement and that the Federal government has a growing arsenal of tools it uses to enforce the Federal health care laws and regulations.  The Department of Justice, the Department of Health and Human […]

With increasing frequency, practitioners and health professional students request patient information and/or access to patients or patients’ medical records for purposes of research.  The requests are particularly difficult to address in small organizations without an Institutional Review Board (IRB).  They can also be difficult to handle because they may be […]

This month, the Health Resources and Services Administration (HRSA) issued additional 340B Program compliance audit results and its final rule on the orphan drug exclusion—clarifying several matters relevant to 340B covered entities amid continuing Program expansion and scrutiny by industry stakeholders.    The federal 340B Drug-Pricing Program requires pharmaceutical manufacturers […]