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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

Bass, Berry & Sims PLC

CMS & HHS Withdraw Appeal to Recent Copay Accumulator Federal District Court Decision: 2020 Accumulator Rule Still in Effect

On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV and Hepatitis Policy Institute et...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

Proskauer - Minding Your Business

A Name is Not Enough: Ninth Circuit Finds No Standing for First-to-File Shareholder to Appeal Securities Class Action

Imagine you are an investor and you decide to file a lawsuit after a company that you invest in suffers a stock drop. When you get to the courthouse, you find that you are the first person to file a federal securities class...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

Kohn, Kohn & Colapinto LLP

The Government’s Ability to Combat Fraud is on the Line in False Claims Act Supreme Court Case

Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

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Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...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

King & Spalding

CMS Proposes for the Third Time to Exclude Section 1115 Uncompensated Care Pool Days from Medicare DSH

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On February 24, 2023, CMS issued a proposed rule that would modify the Medicare Disproportionate Share Hospital (DSH) payment regulation to limit the universe of Section 1115 demonstration beneficiaries who can be “regarded...more

Bass, Berry & Sims PLC

The ABCs of Medicare and Medicaid Claims Audits: Responding to Audits and Potential Consequences from Negative Audits

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As addressed in the first installment of this three-part series, healthcare providers face potential audits from an increasing number of Medicare and Medicaid contractors. Failing to respond properly can lead to significant...more

King & Spalding

CMS Reworks the Medicare Cost Report for Hospitals

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On December 29, 2022, CMS posted on its website Transmittal 18, which implements sweeping changes to the Medicare cost report for hospitals and its accompanying instructions. The revisions affect nearly every facet of...more

Dechert LLP

Don’t Trade on Me: Second Circuit Excludes Confidential Agency Information From the Definition of “Property” in Insider Trading...

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A divided panel of the U.S. Court of Appeals for the Second Circuit held, on December 27, 2022, in United States v. Blaszczak (“Blaszczak II”) that an agency’s confidential, pre-decisional information did not count as...more

Parker Poe Adams & Bernstein LLP

Fifth Circuit Backs Block on Contractor Vaccine Mandate

These days, efforts by the federal government to mandate COVID-19 vaccinations for various groups seem like ancient history. Nevertheless, federal courts continue hearing challenges to the mandates filed by state governments,...more

Foley Hoag LLP

American Hospital Association et al. v. Becerra et al.: Supreme Court Rejects CMS Policy to Adjust Medicare Part B Payments for...

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Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more

Holland & Hart LLP

Small Win for Healthcare Providers: CMS Issues New Guidance under No Surprise Billing Rules and DHHS' Appeal

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On April 12, 2022, CMS issued new guidance for the independent dispute resolution (“IDR”) process under the No Surprise Billing Rules (“Rules”) in response to a U.S. District Court for the Eastern District of Texas judge...more

King & Spalding

D.C. Circuit Rejects Critical Access Hospital’s Appeal for Medicare Payments to On-Call Specialty Physicians

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On April 15, 2022, the D.C. Circuit affirmed the denial of a California hospital’s request to obtain critical access hospital cost reimbursement from Medicare for the costs incurred to keep non-emergency specialty physicians...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

Foley & Lardner LLP

Seventh Circuit Court of Appeals Reiterates Validity of Objective Reasonableness Defense to FCA Claims

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In a 2-1 opinion issued on April 5, the Seventh Circuit Court of Appeals again held that an objectively reasonable interpretation of a relevant statute or regulation precludes the required finding of intent under the False...more

Sheppard Mullin Richter & Hampton LLP

Fifth Circuit Upholds ACA Risk Adjustment Program

Various smaller health insurance issuers have challenged the risk-adjustment program under the Patient Protection and Affordable Care Act (ACA), alleging, among other things, that its underlying methodology favors larger...more

Foley & Lardner LLP

“Objectively Reasonable” Interpretation Defeats FCA Knowledge in 4th Circuit

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The Fourth Circuit Court of Appeals is now the latest in a growing number of courts holding that an objectively reasonable interpretation of governing law defeats the requisite element of intent or “scienter” under the False...more

McDermott Will & Emery

Pending Supreme Court Decision in AHA v. Becerra May Be Felt Well Beyond the Healthcare Industry

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By July 2022, the US Supreme Court is expected to release its opinion in American Hospital Association v. Becerra, a case that not only has significant ramifications for healthcare providers but may also impacts the deference...more

Venable LLP

The Fourth Circuit enforces Safeco's rigorous, objective scienter requirement for Civil False Claims in Sheldon

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On January 25, in United States ex rel. Sheldon v. Allergan, No. 20-2330 (4th Cir., Jan. 25, 2022), the United States Court of Appeals for the Fourth Circuit upheld a lower-court dismissal of a False Claims Act (FCA) case...more

WilmerHale

Fourth Circuit’s Decision Bolsters Trend Toward Objective Scienter Standard Under the False Claims Act

WilmerHale on

On January 25, 2022, in United States ex rel. Sheldon v. Allergan Sales, LLC, a divided panel of the U.S. Court of Appeals for the Fourth Circuit held that a defendant accused of violating the False Claims Act (FCA) by...more

Arnall Golden Gregory LLP

Is There a Constitutional Limit to Excessive Fines in False Claims Act Cases? Eleventh Circuit Says a Million Dollar Fine for a...

In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...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

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