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Notice and Comment Appeals

McDermott Will & Emery

McDermott Submits Amicus Brief to the US Supreme Court in United Behavioral Health

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On January 2, 2024, McDermott filed an amicus curiae brief on behalf of the ERISA Industry Committee (ERIC) and the United States Chamber of Commerce (Chamber) in United Behavioral Health v. David K., No. 23-586, in the US...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - March 2023 #2

Apple Inc. v. Vidal, Appeal No. 2022-1249 (Fed. Cir. Mar. 13, 2023) In our Case of the Week, the Federal Circuit allowed Apple’s challenge to the Patent Trial and Appeal Board’s (“PTAB”) Fintiv rules to proceed, at least...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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights - November 2021: Are Institution Decisions Set in Stone?

The Leahy-Smith America Invents Act granted the Patent Office authority to issue “regulations . . . establishing and governing inter partes review.” 35 U.S.C § 316(a)(4). For the Patent Trial and Appeal Board (“Board”) to...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights - November 2021

The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more

Benesch

November Ends With Flurry of Litigation Regarding Various COVID Vaccine Mandates

Benesch on

As November came to an end, federal courts across the country continue to examine and issue preliminary rulings on challenges to various COVID vaccine mandates put in place by the Biden Administration. At the beginning of...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

Mitchell, Williams, Selig, Gates & Woodyard,...

National Priority List/Superfund: Federal Appellate Court Addresses Challenge to U.S. Environmental Protection Agency Listing...

The United States Court of Appeals for the District of Columbia (“Court”) addressed in a November 13th decision a challenge to a United States Environmental Protection Agency (“EPA”) decision regarding a Comprehensive...more

WilmerHale

Federal Court Blocks Trump Administration's H-1B Visa Rules

WilmerHale on

Judge Jeffrey S. White of the District Court for the Northern District of California on December 1, 2020, set aside two new rules promulgated by the Trump Administration aimed at significantly curtailing the H-1B visa program...more

McDermott Will & Emery

Federal Circuit Will Not Second-Guess IPR Institution Denials

McDermott Will & Emery on

In a series of non-precedential orders, the US Court of Appeals for the Federal Circuit reiterated that it lacks jurisdiction to hear appeals on whether the Patent Trial and Appeal Board properly decided to deny inter partes...more

McDonnell Boehnen Hulbert & Berghoff LLP

Nike, Inc. v. Adidas AG (Fed. Cir. 2020)

The procedural niceties of the U.S. Patent and Trademark Office's implementation of the post-grant review features of the Leahy-Smith America Invents Act continue to be explicated in the Federal Circuit (and of course, the...more

King & Spalding

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

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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

Ogletree, Deakins, Nash, Smoak & Stewart,...

Fifth Circuit Finds EEOC Did Not Have Authority to Issue 2012 Criminal History Guidance

On August 6, 2019, in State of Texas v. Equal Employment Opportunity Commission, the U.S. Court of Appeals for the Fifth Circuit ruled that the Equal Employment Opportunity Commission (EEOC) overstepped its limited rulemaking...more

Morgan Lewis - Health Law Scan

The Zombification of Auer: Supreme Court Cabins Agency Deference in Kisor v. Wilkie

Paired with the recent decision in Azar v. Allina, the healthcare industry in particular can hope for a greater voice in the regulatory process in the wake of the US Supreme Court’s directives. With Allina’s requirement that...more

King & Spalding

Supreme Court Delivers Victory to Providers in Allina DSH Part C Case in a Decision with Broad Implications

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In a major win for providers that serve a disproportionate share of indigent patients, the Supreme Court today upheld the D.C. Circuit’s earlier decision invalidating CMS’s policy to treat beneficiaries enrolled in Part C...more

Mintz - Health Care Viewpoints

Update on Azar v. Allina Health Services: Supreme Court Hears Oral Argument on When CMS Must Use Formal Rulemaking

On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more

Mintz - Health Care Viewpoints

Supreme Court to Decide Critical Case on When CMS Must Use Formal Rulemaking when Instructing Medicare Contractors

On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more

Baker Donelson

Supreme Court Grants Review in Allina Health Services Case

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Is the Department of Health and Human Services (HHS or the government) required to engage in notice and comment rulemaking when it changes a requirement that has an important impact on hospitals' reimbursement? As we reported...more

Baker Donelson

Court Upholds Procedural Validity of HHS's Outlier Reconciliation Instructions

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On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit upheld the procedural validity of 2010 manual instructions setting out the criteria by which Medicare outlier payments might be...more

Baker Donelson

Hospitals Plagued by HHS's 2012 Medicare DSH Calculation Obtain Relief from the D.C. Circuit

Baker Donelson on

Hospitals affected by HHS's 2014 decision to include Medicare Part C enrollees as part of the Medicare fraction of the disproportionate share calculation obtained relief late last month when that position was voided by the...more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Baker Donelson

Court Allows 'Retroactive' Application of 2005 Wage Index Rule Limiting Reimbursement for Pension Plan Costs

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On February 22, 2016, in Regents of the University of California v. Burwell, the U.S. District Court for the District of Columbia granted summary judgment in favor of the Secretary of Health and Human Services (the Secretary)...more

Bradley Arant Boult Cummings LLP

Department of Homeland Security Regulation Benefitting STEM Employers Thrown into Question

A federal district judge recently issued a 37-page decision vacating a 2008 Department of Homeland Security (DHS) regulation that has helped thousands of U.S. companies hire and retain foreign students holding U.S. degrees in...more

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