Category: Corporate Compliance

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 […]

PhRMA Releases Updated Code on Interactions with Health Care Professionals

The Pharmaceutical Research and Manufacturers of America (“PhRMA”) recently issued an updated Code on Interactions with Health Care Professionals (the “Updated Code”). The Updated Code’s preamble states that it reinforces PhRMA’s intentions that interactions with health care professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine. […]

OIG Work Plan Round-up: 9 New Items Added for September – October 2019, Including Medicaid Reimbursement of Specialty Drugs

The Office of Inspector General (OIG) for Health and Human Services (HHS) 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 […]

Q3 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 July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]

OIG Report on Reasonable Assumptions in Manufacturer Reporting

Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of assumptions made by a sample of drug manufacturers participating in the Medicaid Drug Rebate Program (MDRP) […]

OIG Publishes Advisory Opinion on an Arrangement Involving an Excluded Individual

In OIG Advisory Opinion No.19-05, the Department of Health and Human Services Office of the Inspector General (OIG) concluded that it would not impose sanctions against a requestor under the civil monetary provision of the Social Security Act (SSA) that prohibits certain persons from contracting with individuals or entities known […]