The Department of Health and Human Services has released extensive and significant revised final rules governing the Physician Self-Referral Law (the Stark law) and the Medicare Anti-Kickback Statute (AKS) in furtherance of...more
12/21/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Patients ,
Payment Systems ,
Physicians ,
Safe Harbors ,
Self-Referral ,
Stark Law ,
Value-Based Care
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
12/3/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Manufacturers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
The CMS proposed regulation issued on October 17, 20191 provides much needed clarity on the question of when compensation is deemed to vary with the volume or value of referrals or other business generated between the...more
On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more
2/5/2019
/ Anti-Kickback Statute ,
Arm's Length Principle ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fair Market Value ,
Managed Care Contracts ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare Part D ,
OIG ,
Pharmaceutical Benefits Scheme ,
Prescription Drugs ,
Price Reduction Clause ,
Proposed Regulation ,
Public Comment ,
Rebates ,
Safe Harbors
Please see full publication below....more
10/11/2016
/ Acquisitions ,
Affordable Care Act ,
Anti-Kickback Statute ,
Antitrust Investigations ,
Corporate Counsel ,
Due Diligence ,
False Claims Act (FCA) ,
Fee-for-Service ,
Health Care Providers ,
Hospitals ,
Joint Venture ,
Mergers ,
Provider Payments ,
Stark Law ,
Value-Based Payments ,
Venture Capital
The first case to interpret when the clock begins to run on the “60-Day Rule” did not go well for health care providers. On August 3rd, the Southern District of New York rejected defendants HealthFirst, Inc.’s and Continuum...more
In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more
7/27/2015
/ Appeals ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Non-Compete Agreements ,
Nonprofits ,
OIG ,
Physicians ,
Qui Tam ,
Stark Law ,
Treble Damages ,
Tuomey
Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence.
Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more