The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021.
The...more
3/12/2021
/ Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare Part C ,
Opioid ,
Prescription Drugs
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...more
The Situation: Companies facing the twin prospects of a significant Department of Justice ("DOJ") settlement and financial distress have historically had little insight into how the DOJ evaluates an assertion by a company...more
The Situation: The spread of the novel coronavirus (COVID-19) pandemic has significantly impacted the delivery of health care services and increased demand for telehealth services.
The Result: The pandemic has encouraged...more
The Situation: A jury had originally handed down a large verdict in a False Claims Act ("FCA") case that resulted in $347 million judgment. The district court threw out that verdict, however, and the relators appealed.
The...more
The Situation: The two-year grace period for updating agreements of "lawful holders" (i.e., recipients named on patient consent forms obtained pursuant to the Part 2 Rule) with contractors, subcontractors, and legal...more
2/11/2020
/ Confidential Information ,
Consent ,
Disclosure Requirements ,
Drug & Alcohol Abuse ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Patient Privacy Rights ,
SAMHSA ,
Substance Abuse
The Situation: On May 24, 2019, the Department of Health and Human Services ("HHS") issued a new fact sheet clarifying business associates' direct liability for violations of the Health Insurance Portability and...more
The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more
6/16/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
False Claims Act (FCA) ,
Health Care Providers ,
HITECH Act ,
Meaningful Use ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
OIG ,
Risk Mitigation ,
Settlement Agreements ,
Software ,
Third-Party Service Provider