The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: OIG

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OIG

OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services

On April 22, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare organization loaning smartphones to promote telehealth care that it provides to underserved populations. The Advisory Opinion provides context for healthcare organizations that may similarly want… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

OIG Approves Physician-Owned Medical Device Company With Several Safeguards

On April 20, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion regarding physician ownership of a medical device company that manufactures products ordered by the physician owners and other affiliated physicians. Read our alert to learn more about the opinion, which offers a path forward for… Continue Reading
CMS Guidance, OIG, Regulatory

Will 2022 Be The Year? OIG’s 25 Top Recommendations to Reduce Healthcare Fraud

Every year the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) releases an annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Unimplemented Recommendations. HHS released its most recent in Nov. 2021, outlining OIG’s top 25 unimplemented recommendations that, in OIG’s view, would most positively affect… Continue Reading
DOJ, OIG, Regulatory

Increasing OIG and DOJ Telehealth Fraud Enforcement Likely on Horizon

Three McGuireWoods’ attorneys, partners Andrea Lee Linna and Michael Podberesky, and associate Amanda Ray, have co-authored an article on the likely forthcoming increase in OIG and DOJ telehealth fraud enforcement that was published in the July issue of Compliance Today.   The article examines recent enforcement actions against individuals alleged to have committed telehealth fraud as… Continue Reading
CMS Guidance, DOJ, FCA Defenses, FCA Litigation, Investigations, OIG, Regulatory, Settlements, Stark Law

2021’s First-Half Notable Themes on The FCA Insider

As vaccination rates rise, the COVID-19 pandemic continues to reverberate through 2021. These reverberations also impacted the healthcare fraud and abuse landscape that is the basis of The FCA Insider’s coverage. To-date, 2021 has seen more than three dozen posts on topics ranging from False Claims Act (FCA) court opinions, U.S. Department of Justice (DOJ)… Continue Reading
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 Advisory Opinion Allows ASC Joint Venture by Management Company and Hospital-Employed Physicians

On April 29, 2021, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion offering first-time guidance on the development and investment of an ambulatory surgery center owned jointly by a hospital, management company and physician investors employed by the hospital. Read on for analysis of this opinion.… 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
OIG, Regulatory

Rural FQHC Can Provide Free Space for COVID-19 Vaccinations

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

Free FQHC COVID-19 Testing Approved by OIG

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 regulatory… Continue Reading
OIG, Regulatory

American Rescue Plan Funds OIG’s Provider Relief Fund Oversight

On March 11, 2021, President Joe Biden signed into law H.R. 1319, the American Rescue Plan Act of 2021. The American Rescue Plan’s $1.9 trillion in spending, contains numerous provisions impacting healthcare, including medical insurance, services delivery and providers. The American Rescue Plan also provides $5 million to the HHS Office of Inspector General (OIG)… Continue Reading
OIG, Regulatory

Per-Click Compensation for Philanthropic Entity’s COVID-19 Vaccine Site Low Risk of Fraud According to OIG

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 regulatory… 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
CMS Guidance, OIG, Regulatory, Stark Law

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

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) and the federal Anti-Kickback Statute (AKS). This client alert, the latest in McGuireWoods’ summary series on these final rules, focuses… 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
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

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