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Office of the Inspector General Advisory Opinions False Claims Act (FCA)

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more

Bass, Berry & Sims PLC

OIG Approves the Use of Gift Cards to Reward Customers' Marketing Efforts

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On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more

Mintz - Health Care Viewpoints

OIG Issues a Favorable Advisory Opinion on Vendor’s Offer of Gift Cards to Physician Practices for Recommending the Vendor’s...

The Office of Inspector General (OIG) started 2024 with a flurry of activity by issuing four new Advisory Opinions on January 3, 2024. In one of these Advisory Opinions, the OIG approved a vendor’s referral program that...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

King & Spalding

OIG Issues Favorable Advisory Opinion Concluding Bonuses to Employed Physicians Are Not Kickbacks

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Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | September 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA), the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

King & Spalding

OIG Issues Favorable Advisory Opinion on a Drug Manufacturer’s Provision to Hospitals of Trial Units of Antipsychotic Medication...

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On December 22, 2022, OIG issued a favorable advisory opinion concluding that it would not impose administrative sanctions on a pharmaceutical manufacturer for providing trial units of a certain antipsychotic drug (Drug) to...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Bass, Berry & Sims PLC

Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

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On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services...more

King & Spalding

OIG Issues Advisory Opinion on Medical Group’s Proposed Employment of Individual Excluded from Participation in Federal Health...

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On May 25, 2022, OIG posted an Advisory Opinion analyzing a medical group’s proposal to employ an individual excluded from participation in federal health care programs to perform marketing tasks related to workers’...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

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This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January - April 2022

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This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned Device Companies

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more

Proskauer - Health Care Law Brief

OIG Removes Barrier to Requests for and Issuances of Advisory Opinions When the Same Conduct is Under Investigation

On January 11, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued, without an opportunity for public notice and comment, a Final Rule, amending its internal process for...more

Manatt, Phelps & Phillips, LLP

OIG Quietly Revises Bases for Rejecting Advisory Opinion Requests

Responding to industry stakeholder sentiment, the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) recently issued an unexpected final rule that, effective February 10, 2022, will...more

Akin Gump Strauss Hauer & Feld LLP

OIG Joint Venture Advisory Opinion Does Not Consider Multiple Court Decisions That Undermine the Conclusions in its Opinion

 Key Points - HHS-OIG recently issued an Advisory Opinion finding that proposed JV, if undertaken, could constitute prohibited remuneration under the AKS. The scope of material the OIG may consider is limited. The OIG...more

King & Spalding

OIG Issues Favorable Advisory Opinion for Free Drug Sample Arrangement

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On November 10, 2021, OIG issued Advisory Opinion No. 21-16 permitting an arrangement whereby a drug manufacturer (Requestor) provides free samples of a long-acting injectable atypical antipsychotic drug (the Drug) to certain...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Dorsey & Whitney LLP

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes...

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Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal...more

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