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 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
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
11/25/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
MCOs ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Stark Law
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
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
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more
2/11/2019
/ Anti-Kickback Statute ,
Comment Period ,
Drug Pricing ,
Health Insurance ,
Incentives ,
Life Sciences ,
Managed Care Contracts ,
Medicaid ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Prescription Drugs ,
Rebates ,
Regulatory Agenda ,
Safe Harbors ,
Trump Administration
On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that OIG would not pursue enforcement under the Anti-Kickback Statute (AKS) or the...more
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
On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately.
...more
8/16/2018
/ Anti-Kickback Statute ,
Co-payments ,
Drug & Alcohol Abuse ,
Life Sciences ,
Manufacturers ,
New Legislation ,
Opioid ,
Out-of-Pocket Expenses ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State and Local Government
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more
On November 16, 2017, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would revise regulations and clarify requirements for the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more
In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more
Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more
Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more
A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more