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Rulemaking Process Medicaid Medicare

Brownstein Hyatt Farber Schreck

Most-Favored-Nation Drug Pricing in the U.S.

On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

Hogan Lovells

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

Hogan Lovells on

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...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

ArentFox Schiff

Post-Chevron Health Care Regulations: The Dawn of a New Day

ArentFox Schiff on

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more

McDermott Will & Emery

Trending in Telehealth: May 28 – June 3, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Bradley Arant Boult Cummings LLP

Federal Regulators Solicit Comments Regarding Healthcare Point-of-Sale Financing

On July 7, the CFPB, Centers for Medicare & Medicaid Services (CMS), Department of Health & Human Services (HHS), and Department of the Treasury issued a formal request for information regarding forms of consumer-facing...more

McDermott Will & Emery

Trending in Telehealth: July 11 – 17, 2023

McDermott Will & Emery on

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more

Sheppard Mullin Richter & Hampton LLP

Key Healthcare Provisions of the Consolidated Appropriations Act, 2023

Introduction On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic initiatives, including certain...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

Epstein Becker & Green

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

Epstein Becker & Green on

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

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

Seyfarth Shaw LLP

In Case You Missed It: Guidance on Health Care Fraud Enforcement and Compliance

Seyfarth Shaw LLP on

The Houston Bar Association and the University of Houston Law Center Health Law & Policy Institute partnered to host the “Guidance on Health Care Fraud Enforcement and Compliance - A Conversation with HHS Counsel and Other...more

Bricker Graydon LLP

CMS proposes new Stark Law exception for limited remuneration to a physician

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On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more

Bricker Graydon LLP

CMS clarifies the process for correcting mistakes under the Stark Law

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) published proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law)....more

Polsinelli

CMS Delays Price Transparency, Doubles Down on Site-Neutral and 340B Payment Policies in CY 2020 OPPS Final Rule

Polsinelli on

Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Guilt by Association – New Centers for Medicare and Medicaid Services Rule on Provider and Supplier Affiliations

Over the past five years, Centers for Medicare and Medicaid Services (CMS) estimates that $20.7 billion in payments have been made to providers and suppliers involved in affiliations that present undue risk of fraud, waste,...more

Bricker Graydon LLP

CMS proposes to change the way group practices can pay profit shares to physicians under Stark Law

Bricker Graydon LLP on

Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes to the regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, include changes to the special...more

Bricker Graydon LLP

CMS proposes to recalibrate the scope and application of the Stark regulations

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As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more

Ballard Spahr LLP

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more

King & Spalding

District Court Rules that Supreme Court’s Allina Decision Requires Notice-and-Comment Rulemaking for CMS’s Long-Term Care Hospital...

King & Spalding on

On August 22, 2019, the United States District Court for the District of Columbia held that CMS had unlawfully changed its “must-bill” policy, without going through notice-and-comment rulemaking, when it denied bad-debt...more

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