FDA Guidance Details Exemptions and Exclusions from Certain Drug Supply Chain Security Act Requirements Due to COVID-19 Public Health Emergency

On April 30, 2020, the U.S. Food and Drug Administration (“FDA”) published guidance clarifying the nature and scope of exemptions and exclusions to certain requirements under the Drug Supply Chain Security Act (“DSCSA”) triggered by the COVID-19 public health emergency. By waiving certain requirements under the DSCSA for the duration […]

OCR Issues Additional Guidance Regarding Enforcement Discretion in Connection with COVID-19 Community-Based Testing Sites

On April 9, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) announced that it will exercise its enforcement discretion and not impose penalties on covered entities or their business associates for noncompliance with Health Insurance Portability and Accountability Act (“HIPAA”) regulatory […]

Q4 Government Settlements Round-Up: Life Sciences

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in October – December 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Dec. 3, 2019 $3 million Deferred prosecution agreement […]

Drug Pricing 2019 Year in Review

In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while spending months on an array of legislation, did not manage to send anything major to the […]

Five New Items Round Out the OIG’s 2019 Work Plan – LTC, Opioids, Vaccines

The Health and Human Services (HHS) Office of Inspector General (OIG) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be found on the Recently Added page. All current Work Plan items are available on the […]

Sixteen New Items Added to OIG Work Plan in November 2019 – Focus on ASP, AMP, Drug Payments

The Health and Human Services (HHS) Office of Inspector General (OIG) Work Plan describes audits, reviews and other work statutorily required or otherwise undertaken by the OIG. Monthly updates to the OIG Work Plan can be found on the Recently Added page. All current Work Plan items are available on the […]

OIG Announces Updated Hotline for Reporting Fraud, Waste & Abuse

The Department of Health and Human Services (DHHS) Office of Inspector General (OIG) announced yesterday a revamped hotline for reporting fraud, waste, abuse and mismanagement involving DHHS programs. Complaints investigated by the OIG include, among other things, false or fraudulent claims submitted to Medicare or Medicaid; kickbacks or inducements for […]