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Administrative Procedure Act Hospitals

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...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

King & Spalding

Ninth Circuit Vacates Low-Wage-Index Policy

King & Spalding on

On December 11, 2024, the Ninth Circuit struck down an HHS policy that boosted the wage index, and therefore the Medicare reimbursement rate, for hospitals in low-income communities in Kaweah Delta Health Care District v....more

Proskauer - Health Care Law Brief

Post‑Chevron Spotlight: Disproportionate Share Hospital Payments Restored as Texas Hospitals Prevail in Challenge to HHS Exclusion...

In a victory for Texas health care providers, in Baylor All Saints Medical Center dba Baylor Scott & White All Saints Medical Center‑Fort Worth et al. v. Xavier Becerra, case number 4:24‑cv‑00432, the United States District...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

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Holland & Knight LLP

Supreme Court Backs Rule That Decreases Medicare Payments to Safety-Net Hospitals

Holland & Knight LLP on

The U.S. Supreme Court settled an Administrative Procedures Act (APA) dispute on June 24, 2022, involving Medicare's formula to adjust rates paid to safety-net hospitals, clarifying a statute that dictates how to calculate...more

King & Spalding

New Kidney Transplant Allocation Policy Survives Eighth Circuit Legal Challenge

King & Spalding on

On November 8, 2021, the Eighth Circuit affirmed a district court order that denied an attempt to preliminarily block the Organ Procurement and Transplant Network’s (OPTN) policy changing the manner in which donor kidneys are...more

Holland & Knight LLP

Price Transparency in Hospitals – Is Hospital Pricing Data a Protected Trade Secret?

Holland & Knight LLP on

By this point, it's no secret the cost of healthcare services can vary dramatically between different providers of the same services. The Bush, Obama, Trump and Biden administrations all pushed for price transparency in...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Cozen O'Connor

US And Tyler Texas Chambers Of Commerce Sue Feds To Block Portions Of The Health Plan Transparency Rule

Cozen O'Connor on

Two chambers of commerce, the Chamber of Commerce the United States of America and the Tyler (TX) Area Chamber of Commerce, filed a lawsuit on August 10, 2021, in the US District Court for the Eastern District of Texas...more

Bradley Arant Boult Cummings LLP

The Ongoing Saga of the CMS Hospital Price Transparency Rule

The Centers for Medicare & Medicaid Services (CMS) Hospital Price Transparency Rule went into effect on January 1, 2021, but whether it will succeed in making prices readily comparable for healthcare consumers remains to be...more

Foley & Lardner LLP

D.C. Circuit Upholds Hospital Price Transparency: Regulations Paving Way for January 1, 2021 Effectiveness

Foley & Lardner LLP on

On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more

Husch Blackwell LLP

Court Of Appeals Upholds Hospital Price Transparency Rule

Husch Blackwell LLP on

We previously outlined the requirements of the Hospital Price Transparency Rule (the “Rule”), which goes into effect January 1, 2021. Since releasing that blog post, the U.S. Court of Appeals for the District of Columbia...more

Baker Donelson

Federal District Court Upholds CMS Hospital Price Transparency Rule, Reporting to Begin January 1, 2021

Baker Donelson on

On June 23, 2020, a federal district court upheld a Centers for Medicare and Medicaid Services (CMS) regulation that requires hospitals to publicly report information regarding their standard charges, including privately...more

Rivkin Radler LLP

Hospital Price Transparency Rule Upheld

Rivkin Radler LLP on

On June 23, the U.S. District Court for the District of Columbia ruled against the American Hospital Association and other associations and individual hospitals that had sued the U.S. Department of Health and Human Services...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

K&L Gates LLP on

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

King & Spalding

Federal Court Partially Grants Motion to Dismiss Clearing Way for New HHS Liver Allocation Policy to Go into Effect

King & Spalding on

On January 21, 2020, the U.S. District Court for the Northern District of Georgia granted in part and denied in part a motion challenging a new HHS policy for allocating livers to transplant patients in the United States. The...more

Morgan Lewis - Health Law Scan

HHS Analyzes Legal Impact of Allina on Agency Enforcement

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services...more

Polsinelli

CMS Outlines New Standard for Challenging Medicare Payment Denials, Echoing Brand Memo on Force of Sub-Regulatory Guidance

Polsinelli on

On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more

King & Spalding

Victory for Hospitals as Judge Rules that CMS’s Reduction of Medicare Payments for Outpatient E&M Services Was Ultra Vires

King & Spalding on

On September 17, 2019, U.S. District Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia awarded summary judgment in favor a group of more than 40 hospitals on their challenge to CMS’s decision...more

King & Spalding

D.C. Circuit Court Reinstates 2017 Final Rule Limiting Hospitals’ Medicaid Disproportionate Share Hospital (DSH) Funding

King & Spalding on

On August 13, 2019, the U.S. Court of Appeals for the District of Columbia Circuit overturned a district court ruling that CMS’s 2017 final rule on the Medicaid DSH program limit calculation violates the Medicaid Act, 42...more

Polsinelli

Azar v. Allina Health Services: Hospitals Claim (Procedural) Victory in DSH Dispute

Polsinelli on

On June 3, 2019, the Supreme Court issued an eagerly anticipated opinion in Azar v. Allina Health Services, a decision with far-reaching implications both for the calculation of disproportionate share payments and provider...more

Brownstein Hyatt Farber Schreck

Medicare Rulemaking After Azar v. Allina Health Services

The Medicare Program, established in 1965, initially seemed simple: provide health care for senior citizens by paying hospitals and doctors directly for the care the seniors required. Initially, there were two parts to...more

Davis Wright Tremaine LLP

Supreme Court Overturns Disproportionate Share Hospital Payment Policy and Limits CMS Use of Subregulatory Guidance

On June 3, 2019, the U.S. Supreme Court issued its decision in Azar v. Allina Health Services, et al., Case No. 17-1484. The Court ruled in favor of a group of hospitals in a dispute over Medicare disproportionate share...more

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