The state of Connecticut recently enacted HB6669, which requires registration of pharmaceutical manufacturers employing sales representatives who interact with health care professionals (HCPs) in Connecticut. The portions of...more
On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical manufacturer’s sponsored genetic testing and...more
As we recently summarized online here, Oregon has approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15...more
Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15 or more...more
On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals (HCPs). The updated Code will take effect...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain...more
On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more
9/30/2020
/ Advisory Opinions ,
Anti-Competitive ,
Anti-Kickback Statute ,
Anti-Steering Rules ,
Co-payments ,
Department of Health and Human Services (HHS) ,
Manufacturers ,
Medicare ,
Medicare Part D ,
OIG ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Subsidies
Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve allegations that the pharmaceutical...more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
8/16/2019
/ Affordable Care Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Open Payments ,
Opioid ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Sunshine Act
On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more
10/9/2018
/ Anti-Kickback Statute ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Opioid ,
Pain Management ,
Pending Legislation ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Remuneration