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 […]

CMS Updates to Open Payments Program Finalized in CY 2020 Physician Fee Schedule Final Rule

The Centers for Medicare & Medicaid Services (CMS) recently released the CY 2020 Physician Fee Schedule Final Rule (PFS Final Rule) which is expected to be published this week in the Federal Register. CMS previously solicited comments to these changes. Among other things, the PFS Final Rule implements the following […]

Nevada Issues over $17 Million in Fines Against Drug Manufacturers for Failing to Comply with Drug Pricing Transparency Law

Earlier this month, the Nevada Department of Health and Human Services (DHHS) imposed $17.4 million in fines on 21 drug manufacturers for failing to comply with the state’s drug pricing transparency law related to essential diabetes drugs (EDD). This is the first public enforcement action by DHHS in connection with […]