The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: OIG

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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
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

HHS OIG Adds Audit of CARES Act Provider Relief Funds to Work Plan

On May 22, 2020, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) updated its Work Plan to reflect its planned audit of the $50 billion disbursed by HHS to hospitals and other providers under the Public Health and Social Services Emergency Fund (Provider Relief Fund), which McGuireWoods most recently… 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
OIG, Regulatory

OIG Seeks to Minimize Provider Burdens amid COVID-19 Crisis

On March 30, 2020, Christi A. Grimm, Principal Deputy Inspector General of the Department of Health and Human Services (HHS) Office of Inspector General (OIG), issued a letter to the OIG’s website outlining the OIG’s perspective on enforcement during the 2019-novel coronavirus (COVID-19) crisis. Consistent with our recent experiences, OIG stated its desire to minimize… Continue Reading
OIG, Regulatory

OIG Issues Advisory Opinion Approving Supermarket Pharmacy Loyalty Program

On December 17, 2019, the Office of Inspector General (OIG) issued an Advisory Opinion regarding a proposed supermarket loyalty program that would have provided customers with rewards points on out-of-pocket costs related to the purchase of pharmacy products. OIG determined that while the proposal would implicate the Federal anti-kickback statute (AKS) and the prohibition on… Continue Reading
OIG, Regulatory

OIG Redesigned Hotline Webpage

The Office of Inspector General (“OIG”) recently launched a new, redesigned hotline webpage to better guide the public through the tip and complaint reporting process. The OIG hotline operations accepts tips and complaints from all sources regarding potential fraud, waste, abuse, and mismanagement in the U.S. Department of Health and Human Services’ (“HHS”) programs. The… Continue Reading
OIG, Regulatory

Updated Civil Monetary Penalties

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil monetary penalties for inflation annually. Effective November 5, 2019, the Department of Health and Human Services released updated civil monetary penalties for the regulations its agencies are responsible for enforcing. Below are key changes applicable to healthcare providers. The… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

HHS to Ease Fraud and Abuse Rules Part 3: Flexibility for EHR Items and Services, Donated Cybersecurity Tech

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. This client alert, the third in McGuireWoods’ summary series on these proposed rules, focuses… Continue Reading
OIG, Regulatory

HHS to Ease Fraud and Abuse Rules Part 2: Civil Monetary Penalty Law Changes, In-Home Dialysis Telehealth

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services (HHS) announced two proposed rules to 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 second in McGuireWoods’ summary series on these proposed… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

HHS to Ease Fraud and Abuse Rules Part 1: Proposed Revisions to Existing Anti-Kickback Statute Safe Harbors

As discussed in a previous McGuireWoods alert, on Oct. 9, 2019, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law. This client alert, the first in McGuireWoods’ summary series on these proposed rules,… Continue Reading
OIG, Regulatory

OIG Releases Its 2019 Top Recommendations for Health and Human Services Department to Reduce Fraud

Last month, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) released its annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations. This publication outlines the OIG’s top 25 unimplemented recommendations that, in OIG’s view, would most positively affect HHS programs in terms of cost… Continue Reading
OIG, Regulatory

“Health Care Fraud Impacts Everyone”: Miner Emphasizes DOJ’s Ongoing Dedication to Combatting Fraud

Matthew S. Miner, Deputy Assistant Attorney General of the Criminal Division at the U.S. Department of Justice, gave the keynote speech at the 29th Annual National Institute of Health Care Fraud, held in New Orleans, LA. In his speech, Miner, who supervises the Criminal Division’s Fraud and Appellate Sections, emphasized the DOJ’s continued commitment to… Continue Reading
Individual Liability, OIG, Regulatory

DOJ’s Travel Act Prosecution Yields Convictions for Kickbacks Involving Private Payers

As detailed in our prior entry, on April 9, 2019, a Forest Park, Texas jury found seven individuals guilty of various charges related to a scheme engaged in by Forest Park Medical Center (“FPMC”). The physician-owned surgical hospital paid more than $40 million in bribes and kickbacks to induce surgeons to use FPMC to perform their services,… Continue Reading

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