While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
• Review the AdvaMed Code revisions with an eye towards other key fraud and abuse, transparency and compliance issues on the horizon: the expansion of the Sunshine Act and anticipated regulatory changes to address value-based...more
3/6/2019
/ AdvaMed ,
Ethics ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Policies and Procedures ,
Regulatory Oversight ,
Sunshine Act ,
Technology Sector ,
Transparency ,
Value-Based Care
• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more
3/5/2019
/ Bulk Purchasing ,
DQSA ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Outsourcing Facilities ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians
If you read one thing...
- FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more