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 […]
Health Law Alert
HRSA Issues Additional 340B Compliance Audit Reports and Program Rules
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 […]
Physician Licensure Discipline – Narcotics and Pain Management
Recent Nebraska disciplinary actions based on lax physician narcotic prescription practices suggest that it would be worthwhile for hospital and clinic medical staff to review their states’ published guidance on pain management practices. Not only do lax narcotic prescription practices place licensure at risk, but disciplinary action short of license […]
CMS Clarifies the Expanded Role of Telemedicine in Delivering CAH Emergency Services
Conditions of Participation On June 7, 2013, CMS released a helpful Memorandum1 clarifying the role that telemedicine can play in meeting CAH emergency room standards, both under conditions of participation and for EMTALA compliance. The Memorandum was triggered by widespread “misconceptions” on the part of critical access hospitals about whether […]
Community Health Needs Assessments – Proposed Rules Issued by the IRS
Tax-exempt hospitals are required by section 501(r) of the Internal Revenue Code to perform a community health needs assessment (“CHNA”) at least once every three years. Tax-exempt hospitals must both perform and complete a CHNA and formally adopt an implementation strategy based on the CHNA by the end of their […]