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McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Hendershot Cowart P.C.

CMS, Qlarant Scrutinizing Medicare Claims for Skin Substitute Treatments

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Our firm is seeing an uptick in Medicare demand letters for the recovery of overpayment for skin substitutes, such as WoundFixTM, Biobrane, Dermagraft®, AmnioBand®, or AlloPatch®, used in the treatment of wounds. CMS auditors...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

McDermott Will & Emery

Sixth Circuit Loosens Anti-Kickback Statute’s Grip in FCA Cases

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The Anti-Kickback Statute (AKS) is a criminal statute that, in broad strokes, bars the payment or receipt of “remuneration” in exchange for referrals. It has become one of the most lucrative theories of civil liability under...more

McDermott Will & Emery

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

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After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

Bass, Berry & Sims PLC

OIG Closes the Door on Coalition-Model Patient Assistance Programs in its Latest Advisory Opinion

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On October 5, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion No. 22-19, finding that a proposal by an entity funded entirely by manufacturers of oncology...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

McDermott Will & Emery

McDermott’s Healthcare Enforcement Quarterly - Q1 2022

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The healthcare enforcement landscape is shifting quickly. This issue of McDermott’s Healthcare Enforcement Quarterly examines emerging trends and key issues for organizations that may become subject to enforcement scrutiny,...more

King & Spalding

Court of Appeals Affirms Ruling that Hospital Utilization Review Committee’s Medicare Part A Inpatient Reclassifications Trigger...

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On January 25, 2022, the U.S. Court of Appeals for the Second Circuit affirmed a lower court ruling that the Secretary of HHS violated the due process rights of Medicare beneficiaries by failing to provide an administrative...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

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On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

ArentFox Schiff

340B “Saga” Works Its Way Through the Courts: What Manufacturers Need to Know

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A handful of recent court decisions have brought a small degree of resolution and simultaneously a large degree of uncertainty to what we at Arent Fox affectionately refer to as the “340B Saga.” It’s a dispute lasting...more

Miles & Stockbridge P.C.

Whistleblowers Don’t Have Super Powers: Whistleblower Protections Don’t Equal Workplace Immunity

Whistleblowers who report perceived illegal activity by an individual, agency, or organization have long been heralded as heroes, serving both the public and private sectors by producing evidence of wrongdoing despite great...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

Foley Hoag LLP - Medicaid and the Law

The Availability of a Private Right of Action in Medicaid

A few years ago, we told you about the “ongoing saga” surrounding the ability of a Medicaid beneficiary or a provider of health care services to a Medicaid beneficiary to challenge a state Medicaid agency’s putative violation...more

Arnall Golden Gregory LLP

OIG Weighs-In on the Review of Extrapolated Overpayments in the Medicare Appeals Process

The financial stakes are often very high for providers when statistical sampling and extrapolation is used to calculate an alleged Medicare overpayment. In post-payment audits involving extrapolation, an actual claims denial...more

Husch Blackwell LLP

COVID-19 Hasn't Interrupted Everything: Certain Hospice Audit Activity Continues Despite Public Health Emergency

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COVID-19 threw a wrench into certain hospice audit activity, but the machine rumbles on. In today’s podcast episode, Husch Blackwell's Meg Pekarske, Erin Burns and Bryan Nowicki discuss the current state of hospice audits,...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 3: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more

Holland & Knight LLP

Healthcare Law Update: September 2017

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OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Baker Donelson

Stark Litigation: The Tuomey Saga Draws to a Close

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In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more

BakerHostetler

ALJ Appeals Frequently Favorable To Providers; OIG Calls For Reforms

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The OIG recently published a report reviewing the implementation of 2005 regulations regarding the administrative law judge (ALJ) level of appeals, the third level of the Medicare appeals system. The 2005 regulatory changes...more

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