The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
7/10/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Working Groups
In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more
The COVID-19 pandemic has led to rapid and drastic changes to health care delivery in the United States, including as it relates to arrangements between health care providers and physicians that may implicate the federal...more
On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting...more
In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the...more
11/21/2019
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Regulatory Standards ,
Request For Information ,
Stark Law
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more
9/10/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Regulation ,
Safe Harbors
Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months. Most recently, a...more
On February 9, President Trump signed the Bipartisan Budget Act of 2018 (“BBA”) into law. The BBA funds the federal government through March 23 and included a bipartisan agreement to increase annual spending authority for a...more
2/22/2018
/ ACOs ,
Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Fraud and Abuse ,
Health Care Providers ,
Medicaid ,
Medicare ,
Penalties ,
Physician Fee Schedule ,
Stark Law ,
Telehealth
On July 18, 2017, the United States Attorney’s Office for the Northern District of Illinois announced that it was creating a new unit located in Chicago within the office’s Criminal Division dedicated to prosecuting criminal...more