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Appeals Administrative Procedure Act Centers for Medicare & Medicaid Services (CMS)

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Morgan Lewis - Health Law Scan

Courts Diverge in Challenges to CMS's Minimum Staffing Requirements for LTC Facilities

On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our...more

Baker Donelson

Federal Court Vacates LDT Final Rule

Baker Donelson on

The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more

Whiteford

Client Alert: Court Strikes Down Nursing Home Staffing Mandate

Whiteford on

In a major victory for nursing homes and long-term care industry advocates, on Monday, April 7, 2025, Judge Matthew J. Kacsmaryk of the US District Court for Northern Texas struck down a Centers for Medicare & Medicaid...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

Federal COVID-19 Mandates and Lawsuit Roundup

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Lawsuits challenging the CMS Interim Final Rule (IFR) on COVID-19 vaccine requirements for healthcare workers and Occupational Safety and Health Administration’s (OSHA) COVID-19 Emergency Temporary Standards on Health Care...more

Holland & Knight LLP

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

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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

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

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

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

King & Spalding

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

King & Spalding on

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

Jones Day

D.C. District Court Vacates 60-Day Medicare Advantage Overpayment Rule

Jones Day on

The Situation: In 2016, several Medicare Advantage ("MA") organizations challenged a 2014 final rule promulgated by the Center for Medicare Services ("CMS") that broadly subjected MA organizations to potential liability under...more

Baker Donelson

Supreme Court Grants Review in Allina Health Services Case

Baker Donelson on

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

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...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

Baker Donelson

D.C. Circuit Precludes Review of DSH Uncompensated Care Data

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On July 26, 2016, the United States Court of Appeals for the District of Columbia Circuit decided Fla. Health Sciences Ctr. v. Burwell. In that case, the Court analyzed a statutory bar against judicial review of estimates...more

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