The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Tag Archives: anti-kickback statute

OIG, Regulatory

Providers May Offer Incentives to Federal Beneficiaries for Receiving COVID-19 Vaccine

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Removes Mandatory Cost-Sharing Obligations for COVID-19 Ambulance Transport Waiver

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to… Continue Reading
Damages, FCA Litigation

Sixth Circuit Creates Circuit Split, Allows Former Employee’s FCA Retaliation Claim

The U.S. Court of Appeals for the Sixth Circuit held, in connection with an interlocutory appeal, that the False Claims Act (FCA) anti-retaliation provisions protect relators from post-employment retaliatory conduct.  In United States ex rel. Felten v. William Beaumont Hosp., 993 F.3d 428 (6th Cir. 2021), the Sixth Circuit reversed the district court’s dismissal of… Continue Reading
DOJ, FCA Defenses, Individual Liability

Eleventh Circuit Affirms 11-year Prison Sentence for Substance Abuse Treatment Center Physician

Last month, the Eleventh Circuit upheld the conviction and 11-year prison sentence of a physician-Medical Director of two substance abuse treatment centers in Florida who was convicted by a jury of participating in a conspiracy to commit healthcare fraud.  On appeal, Arman Abovyan, a board-certified internal medicine physician, challenged his convictions based on insufficiency of… Continue Reading
OIG, Regulatory

Fraud and Abuse Rules Part IV: Final Changes to Existing and New Anti-Kickback Statute Safe Harbors

As discussed in a prior McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. The final rules discussed in this alert were originally given a Jan. 19, 2021, effective date.… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the latest in McGuireWoods’ summary series on these final… Continue Reading
OIG, Regulatory

Fraud and Abuse Rules Part I: Changes to Patient Inducement and Kickback Policies

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the first in McGuireWoods’ summary… Continue Reading
Defense Arguments, OIG, Stark Law

MedMal Plaintiff Uses Anti-Kickback and Stark to Avoid Summary Judgment

A federal court recently allowed a plaintiff’s state law negligence claim, which utilized the Anti-Kickback Statute (“AKS”) and federal physician self-referral law (the “Stark Law”) as legal support to survive a motion for summary judgment. In Post v. AmerisourceBergen Corporation, No. 1:19-CV-73 (N.D.W. Va. Nov. 2, 2020), Plaintiff, Frances G. Post, filed suit against Defendants,… Continue Reading
DOJ, FCA Litigation, OIG

Eleventh Circuit Holds “Knowingly and Willfully” Does Not Require Motive for Kickback Recipient

A recent Eleventh Circuit opinion clarified the mens rea burden the Government must prove to establish criminal intent to violate the Federal Anti-Kickback Statute (“AKS”) for a recipient or payee of a kickback or bribe under 42 U.S.C. § 1320a-7b(b)(1), and affirmed a conviction against a healthcare provider.  The opinion in United States v. Alap Shah… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

HHS Finalizes Stark Law, AKS Changes to Reduce Burdens on Healthcare Providers

On Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published two long-awaited final rules significantly amending the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. These new rules are a direct result of HHS’ Regulatory Sprint to Coordinated Care, and largely adopt… Continue Reading
Defense Arguments, DOJ, Individual Liability, Investigations

Fifth Circuit Upholds Health Care Fraud Convictions for Home Health Agency Employees

The U.S. Fifth Circuit recently upheld convictions and sentences against five named defendants, each charged with conspiracy to commit health care fraud, conspiracy to violate the Federal Anti-Kickback Statute (AKS) and several counts of substantive health care fraud.  In United States v. Barnes, No. 18-31074, 2020 WL 6304699 (5th Cir. Oct. 28, 2020), the Fifth… Continue Reading
OIG, Regulatory

OIG Issues Special Fraud Alert That Challenges Industry Norms Regarding Speakers Programs

On Nov. 16, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a special fraud alert addressing fraud and abuse concerns with speakers programs conducted by pharmaceutical and medical device companies. While the fraud alert reiterates historical OIG and Department of Justice (DOJ) concerns regarding speakers programs, it… Continue Reading
OIG, Regulatory

OIG Responds to Free/Discounted Lodging and Free Antibody COVID-19 Test Inquiries

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Updates Enforcement Responses to COVID-19 Arrangement Inquiries

As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide… Continue Reading
OIG, Regulatory

OIG Requests Inquiries on Enforcement Related to COVID-19 Arrangements

On April 3, 2020, OIG issued a process for inquiries to be submitted to OIG about the application of administrative enforcement authorities against certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG particularly asked for inquiries related to the Federal anti-kickback statute and civil monetary penalties prohibition on beneficiary inducements, where enforcement discretion… Continue Reading
OIG, Regulatory

OIG Follows the Stark Law COVID-19 Waivers for Anti-Kickback Statute

On April 3, 2020, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a policy statement announcing that the OIG will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for remuneration related to the 2019 novel coronavirus (COVID-19). OIG’s announcement follows… Continue Reading

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