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HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations - On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more

CMS Publishes Monumental Changes and Updates to the Physician Self-Referral (Stark) Law Regulations

The Robinson+Cole Health Law Group is committed to examining and reporting on issues important to the health care and life sciences industries. Below are excerpts from our Health Law Diagnosis blog, where we post on fraud and...more

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the...more

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of...more

Government Releases Proposed Changes to Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Regulations;...

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions to the federal Physician Self-Referral Law (the Stark Law), the...more

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System...

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were...more

OIG Posts Telemedicine Advisory Opinion

The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items...more

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more

House Bipartisan Act Would Amend Stark Law and Medicare Part B

On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law...more

OIG Issues Favorable Advisory Opinion for Cost-Sharing Waiver and Stipend Arrangements in a Government-Funded Clinical Research...

The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more

OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more

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