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
The United States Court of Appeals for the Fourth Circuit recently affirmed a $114 million judgment in a protracted, and hotly contested, suit filed under the qui tam provisions of the False Claims Act (FCA) against the owner...more
Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize and clarify” the physician self-referral (Stark)...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) adopted additional revisions to the Stark Law regulations (the final...more
12/1/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Patient Referrals ,
Physicians ,
Stark Law ,
Value-Based Care
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
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
The Office of Inspector General for the U.S. Department of Health and Human Services (HHS-OIG) announced the launch of a portal that will post announcements and information issued by OIG that are related to COVID-19. ...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more
10/21/2019
/ Anti-Kickback Statute ,
Carve Out Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Life Sciences ,
Patient Referrals ,
Proposed Regulation ,
Regulatory Agenda ,
Stark Law ,
Value-Based Care
Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more
10/14/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Burden ,
Regulatory Reform ,
Rulemaking Process ,
Safe Harbors ,
Secretary of HHS ,
Stark Law ,
Value-Based Care ,
Value-Based Payments
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
Last week, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 18-10, advising that the OIG would not pursue an enforcement action under the Anti-Kickback Statute (AKS)...more
On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more
8/29/2018
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Medicare Shared Savings Program ,
OIG ,
Request For Information ,
Safe Harbors ,
Stark Law
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
With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more
1/13/2017
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Exclusions ,
False Claims Act (FCA) ,
Final Rules ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
OIG ,
Safe Harbors ,
Social Security Act