Month: October 2019

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 […]

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 […]

HHS Releases Long-Awaited Proposed Rules Related to AKS, Stark, CMP Laws for Value-Based and Coordinated Care Arrangements

The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. As previously discussed, these proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care and arise from […]

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 […]