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Statutory Interpretation Department of Health and Human Services (HHS)

Hogan Lovells

Supreme Court affirms constitutionality of U.S. Preventive Services Task Force

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On June 27, 2025, the Supreme Court in Kennedy v. Braidwood Management, Inc. upheld the structure of the U.S. Preventive Services Task Force (USPSTF, or “Task Force”), overturning a Fifth Circuit decision that had ruled that...more

King & Spalding

Supreme Court Decision Is A Win for Preventative Services Providers

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Last week, in a 6-3 decision, the Supreme Court overturned a Fifth Circuit decision holding that HHS-appointed United States Preventative Task Force (USPTF) members are inferior officers that do not need to be approved by the...more

Wilson Sonsini Goodrich & Rosati

Texas District Court Vacates 2024 HIPAA Rule Designed to Enhance Reproductive Healthcare Privacy, Effective Nationwide

On June 18, 2025, the United States District Court for the Northern District of Texas vacated most of the rules designed to enhance reproductive healthcare privacy promulgated by the U.S. Department of Health and Human...more

Ballard Spahr LLP

Two Recent Supreme Court Injunction Rulings Support Affordable Care Act

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Two recent U.S. Supreme Court rulings support provisions of the Affordable Care Act, one directly and one indirectly....more

Seyfarth Shaw LLP

SCOTUS on ACA Challenge: Seriously Guys, We’re Doing This Again?

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In a closely watched decision, the Supreme Court has upheld the authority of the U.S. Preventive Services Task Force (Task Force), preserving the Affordable Care Act’s (ACA) requirement that health plans cover preventive...more

Akerman LLP - Health Law Rx

Federal Court Vacates 2024 HIPAA Privacy Rule Modifications That Supported Reproductive Healthcare Privacy: What Regulated...

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an order in Purl v. United States Department of Health and Human Services, No. 2:24-CV-228-Z (N.D. Tex. 2025) (the June 18 Order) that...more

Proskauer - Health Care Law Brief

No Surprises Here! Fifth Circuit Holds NSA Provides No Private Right of Action to Enforce IDR Awards, Deepening Judicial Divide...

In a recently issued opinion, the Fifth Circuit has added yet another chapter to the growing debate over whether providers may seek judicial enforcement of Independent Dispute Resolution (“IDR”) awards issued under the No...more

Pullman & Comley - Labor, Employment and...

Federal Court Decision Reshapes ACA Enforcement by HHS and IRS

The recent federal district court decision in Faulk Company, Inc. v. Xavier Becerra, et al., No. 24-cv-00609-P (N.D. Tex. 2025) significantly alters the primary mechanism used by the U.S. Department of Health and Human...more

King & Spalding

Affordable Care Act Preventative Care Mandate At Risk Pending Supreme Court Decision

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A case pending before the Supreme Court could jeopardize the Affordable Care Act’s (ACA) mandate that certain preventive services be provided on a first dollar coverage basis to plan members. Kennedy v. Braidwood Management...more

Dinsmore & Shohl LLP

D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models

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Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III (June 2025 Update)

McDermott+ on

UPDATE: On May 30, 2025, the Fifth Circuit granted the TMA III plaintiffs’ petition for rehearing en banc, which was previously filed on December 16, 2024. Of note, the Fifth Circuit’s mandate has not yet been issued, so as a...more

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

Dorsey & Whitney LLP on

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

Epstein Becker & Green on

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

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