News & Analysis as of

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

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

Foley & Lardner LLP

Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule

Foley & Lardner LLP on

A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Arnall Golden Gregory LLP

Lawsuit Challenges Hospice Special Focus Program Rule and List

A group of four state associations and a hospice provider have filed a federal lawsuit in Texas challenging the Special Focus Program (“SFP”) Final Rule and the resulting list of hospices identified as poor performers. The...more

ArentFox Schiff

No More Surprise Medical Bills: Texas Court Again Vacates Arbitration Provisions of Surprise Billing Rule

ArentFox Schiff on

On February 6, 2023, health care providers scored a second significant victory when a federal court in Texas again vacated portions of the Biden Administration’s rules governing the arbitration procedures to resolve surprise...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

Wiley Rein LLP

Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?

Wiley Rein LLP on

In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more

Wiley Rein LLP

Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?

Wiley Rein LLP on

In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...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

McDermott Will & Emery

Executive Order on Hospital Price Transparency May Prompt Disclosure of Negotiated Prices

McDermott Will & Emery on

President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...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

Jones Day

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

King & Spalding

CMS Releases FY 2017 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System Final...

King & Spalding on

On August 2, 2016, CMS released a final rule (Final Rule) with updates to the Hospital Inpatient Prospective Payment System (Hospital IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) affecting...more

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