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Statutory Interpretation Department of Health and Human Services (HHS)

Proskauer - Health Care Law Brief

Disproportionate Impact: Supreme Court Narrows Disproportionate Share Hospital Reimbursement to Supplemental Security Income Cash...

The U.S. Supreme Court has issued a significant ruling affecting hospitals that serve low-income Medicare beneficiaries, narrowing the interpretation of the Disproportionate Share Hospital (“DSH”) payment formula. In...more

King & Spalding

Supreme Court Holds that Those “Entitled to Supplemental Security Income Benefits” Means Receiving Cash Payment for Hospital DSH...

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Last week, the Supreme Court issued its opinion in Advocate Christ Medical Center v. Kennedy, siding with the government and holding that, for purposes of the Medicare disproportionate share hospital (DSH) calculation,...more

Robinson+Cole Health Law Diagnosis

U.S. Supreme Court Denies DSH Hospitals’ Attempts to Seek Higher Medicare Payments

On April 29, 2025, the U.S. Supreme Court issued an opinion upholding the formula the U.S. Department of Health and Human Services (HHS) utilized to calculate Medicare hospitals’ disproportionate share hospital (DSH) payment...more

Epstein Becker & Green

Similar Language But a Different Outcome: Medicare DSH Payments after Advocate Christ Medical Center v. Kennedy

Hospitals that serve a high number of indigent patients are faced with a dilemma: they must provide high-quality care but fixed Medicare reimbursement rates often do not take into account the higher operating costs that they...more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Dorsey & Whitney LLP

The Supreme Court Update - April 30, 2025

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On Tuesday, April 29, the Supreme Court of the United States issued one decision: Advocate Christ Medical Center v. Kennedy, No. 23-715: This case addresses the proper method for calculating the “disproportionate share...more

Epstein Becker & Green

A Common Denominator Governs the Medicare Fraction - SCOTUS Today

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In its 2022 decision in Becerra v. Empire Health Foundation, for Valley Hospital Medical Center, the U.S. Supreme Court held that the phrase “entitled to [Medicare Part A] benefits” applied to “all those qualifying for the...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Advocate Christ Medical Center, et al. v. Kennedy

On April 29, 2025, the U.S. Supreme Court decided Advocate Christ Medical Center, et al. v. Kennedy, No. 23-715, holding that for purposes of calculating the Medicare fraction, an individual is entitled to supplemental...more

Arnall Golden Gregory LLP

Court Strikes Down Nursing Home Minimum Staffing Rule

On April 7, 2025, the United States District Court for the Northern District of Texas ruled in favor of the American Health Care Association (“AHCA”) in its lawsuit against Health and Human Services (“HHS”) Secretary Robert...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

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In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Ropes & Gray LLP

District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

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On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

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A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

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Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Seyfarth Shaw LLP

HHS’ Withdrawal of 2022 Guidance Raises Questions about Coverage for Gender-Affirming Care

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In a move with potentially significant implications for entities subject to the Affordable Care Act, the Department of Health and Human Services (HHS) has reversed course and now contends that Section 1557 of the Affordable...more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

Epstein Becker & Green

What Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a False...

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Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction...more

Foley & Lardner LLP

Anti-Kickback Statute Premised False Claims Cases: The “But For” Causation Standard Finds Support from First Circuit

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It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

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On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more

Bass, Berry & Sims PLC

Healthcare Private Equity: What to Expect for the Rest of 2024

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Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more

Parker Poe Adams & Bernstein LLP

Two Recent Supreme Court Decisions Could Dramatically Impact Health Care Regulatory Challenges at the Federal and State Levels

For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more

Ballard Spahr LLP

Courts Invalidate ACA Regulations Following Demise of Chevron Deference

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Following the U.S. Supreme Court’s recent decision to overturn its landmark 1984 Chevron decision, three district courts have struck down provisions in nondiscrimination regulations under the Affordable Care Act that prohibit...more

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