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Rulemaking Process Centers for Medicare & Medicaid Services (CMS) Health Care Providers

McDermott+

Price Transparency: A Regulatory Priority

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The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

ArentFox Schiff

No More Surprise Medical Bills: Providers Score Yet Another Victory as Texas Court Again Vacates Provisions of Biden...

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On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked...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

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

Bass, Berry & Sims PLC

CMS Revises Stark Law Indirect Compensation Arrangement Definition, Again

Bass, Berry & Sims PLC on

The CY 2022 Medicare Physician Fee Schedule final rule includes further revisions to the definition of the term “indirect compensation arrangement” under the federal physician self-referral prohibition (Stark Law). Less than...more

Proskauer - Health Care Law Brief

CMS Corrects Inadvertent Omissions in Recent Stark Law Regulatory Amendments, Clarifies Reach of the Prohibition Related to...

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released its final rules for the 2022 Medicare Physician Fee Schedule (PFS Final Rule) and 2022 Medicare Hospital Outpatient Prospective Payment System...more

Womble Bond Dickinson

The Biden Administration Expands Staff Vaccination Requirement to All Medicare & Medicaid Participating Providers/Suppliers.

Womble Bond Dickinson on

The Biden Administration, through the Centers for Medicare and Medicaid Services (“CMS”) and via Interim Final Rulemaking (“IFR”), has expanded vaccination requirements in many health care settings. Effective November 5,...more

Sheppard Mullin Richter & Hampton LLP

CMS Backs Off Price Transparency for Providers and Plans

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other...more

Epstein Becker & Green

[Webinar] The Future of CMS: A Conversation with Three Former CMS Administrators - July 15th, 12:00 pm - 1:00 pm ET

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Epstein Becker Green invites you to join former CMS Administrators Tom Scully, Leslie Norwalk, and Marilyn Tavenner for a unique panel discussion on their thoughts, advice, and predictions for President Biden’s newly...more

Bricker Graydon LLP

CMS proposes changes to Promoting Interoperability program in IPPS Rule

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On April 27, 2021, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule for the fiscal year 2022 Inpatient Prospective Payment System (IPPS). The IPPS Proposed Rule contained a number of changes to...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

Sheppard Mullin Richter & Hampton LLP

Permanent Expansion of Medicare Telehealth Services

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Foley Hoag LLP

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

Foley Hoag LLP on

On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

Seyfarth Shaw LLP

CMS Announces Extension on Publishing Final Rule Governing Physician Self-Referrals in Stark Law

Seyfarth Shaw LLP on

Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more

Bricker Graydon LLP

COVID-19 Update: CMS and ONC delay interoperability rules

Bricker Graydon LLP on

On April 21, 2020, the Department of Health and Human Services (HHS) announced a policy of enforcement discretion regarding compliance with the recently released interoperability final rules. This new policy will afford the...more

Jones Day

Proposed Revisions to Stark Law and AKS Protections for Electronic Health Records Donations

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The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

McDermott Will & Schulte

Healthcare Enforcement Quarterly Roundup - Q4 2019

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

Bricker Graydon LLP

The new price transparency rule: Are you ready?

Bricker Graydon LLP on

On November 27, 2019, the Centers for Medicare and Medicaid Services (CMS) published its final rule outlining new price transparency requirements as part of the 2020 update to the Outpatient Prospective Payment System....more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act - Year In Review: Five Decisions That Will Affect the Future of FCA Litigation - The Salcido Report: False Claims...

Key Points: - False Claims Act plaintiff cannot use discovery to satisfy Fed. R. Civ. P. 9(b). - Payment of fair market value is a dispositive defense in FCA actions alleging a violation of the Anti-Kickback Statute. ...more

Burr & Forman

Proposed Stark Law Changes May Impact Physician Compensation Models

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On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) proposed sweeping changes to the federal Physician Self-Referral Law, commonly referred to as the Stark Law. While many of the changes reflect CMS’...more

Baker Donelson

The Nightmare Came True: Minor Licensing Actions Could Lead to Disastrous Collateral Damages

Baker Donelson on

As forewarned, CMS's finalization of the Calendar Year (CY) 2020 Physician Fee Schedule, effective January 1, 2020, brings significant changes to its authority to deny or revoke a Medicare enrollment for physicians and other...more

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