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Department of Health and Human Services (HHS) Medicare Administrative Procedure Act

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Bradley Arant Boult Cummings LLP

The Overturn of Chevron: A New Design for Healthcare Law

On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on...more

Stevens & Lee

A New Arena for Future Challenges to CMS Regulations – the Overturn of Chevron

Stevens & Lee on

On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more

Foley & Lardner LLP

What Does the End of Chevron Deference Mean for Federal Health Care Programs?

Foley & Lardner LLP on

On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...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

D.C. District Court Upholds HHS’s Audits of Hospitals’ Worksheet S-10 and Resulting Adjustments When Determining Medicare DSH...

King & Spalding on

On August 30, 2021, the United States District Court for the District of Columbia ruled in favor of HHS and dismissed claims related to improper audits that resulted in adjustments to plaintiff hospitals’ Worksheet S-10 that...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

Foley Hoag LLP - Medicaid and the Law

The Avon Nursing Case: A Lesson in Challenging Medicaid Rulemaking for Providers

Medicaid providers seeking to directly challenge HHS rulemaking recently found success in the 2nd Circuit. In the recent case of Avon Nursing & Rehab v. Becerra, the court sided with a skilled nursing home provider bringing a...more

Holland & Knight LLP

Healthcare Policy Outlook with a Democratic-Controlled Senate

Holland & Knight LLP on

The victories by Democrats Raphael Warnock and Jon Ossoff in the Georgia elections mean that incoming majority leader Chuck Schumer (D-N.Y.) will preside over the narrowest possible majority in the U.S. Senate under which...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

King & Spalding on

On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...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

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

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...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

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

Arnall Golden Gregory LLP

Supreme Court Rules in Favor of Hospitals in HHS DSH Payment Dispute

On June 3, 2019, the Supreme Court of the United States (SCOTUS) issued an opinion in Azar v. Allina Health Services whereby it ruled that the United States Department of Health and Human Services (HHS) violated the Medicare...more

McGuireWoods Consulting

Supreme Court Rules HHS Cannot Take Short-Cuts in Rulemaking

In a 7-to-1 decision, the U.S. Supreme Court on June 3, 2019, held that “Because the Department of Health and Human Services neglected its statutory notice-and-comment obligations when it revealed a new policy that...more

Foley & Lardner LLP

What You Want to Know about the Supreme Court’s Recent Allina Decision

Foley & Lardner LLP on

In a landmark decision on June 3, 2019, the Supreme Court held that the Department of Health and Human Services (HHS) was required to engage in notice and comment rulemaking before publishing methodology (Medicare Fractions)...more

White and Williams LLP

Supreme Court Victory for Hospitals in Medicare Billing Dispute

White and Williams LLP on

On June 3, 2019, the United States Supreme Court issued its decision in Azar v. Allina Health Services, delivering a multi-billion dollar victory for hospitals that serve a disproportionate share of low-income patients by...more

Hogan Lovells

U.S. Supreme Court ruling expands scope of Medicare notice-and-comment requirement

Hogan Lovells on

On 3 June 2019 the U.S. Supreme Court held in Azar v. Allina Health Services that Medicare interpretive guidance must go through notice-and-comment if it establishes or changes a substantive legal standard governing payment,...more

Sheppard Mullin Richter & Hampton LLP

SCOTUS Rejects CMS DSH Policy, Calls CMS Guidance Practices Into Question

Earlier this week, the Supreme Court upheld a D.C. Circuit Court decision vacating a policy of the Centers for Medicare and Medicaid Services (“CMS”) that would have “dramatically – and retroactively – reduced payments to...more

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