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Proposed Rules Hospitals Department of Health and Human Services (HHS)

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

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On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

Alston & Bird

Health Care Week in Review | House and Senate Agree to Budget Resolution; CMS Releases Inpatient and Post-Acute Payment Proposed...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Emery

HHS Issues Provider Information Blocking Disincentives Proposed Rule

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On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more

Bass, Berry & Sims PLC

HHS Proposes Rule to Establish Disincentives for Healthcare Providers That Engage in Information Blocking

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In 2020, when the U.S. Department of Health and Human Services (HHS) published its Final Rule to implement the information blocking prohibitions of the 21st Century Cures Act, HHS left healthcare providers wondering what...more

Holland & Knight LLP

HHS Proposes Information Blocking Disincentives for Healthcare Providers

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Two divisions of the U.S. Department of Health and Human Services (HHS) – the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) – released the "21st Century Cures Act:...more

Holland & Knight LLP

Holland & Knight Health Dose: July 18, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

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The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

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The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

Cozen O'Connor

HHS Proposes $9 Billion Lump Sum Payment for Hospitals to Remedy Unlawful 340B Payment Reductions

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On Friday, July 7, 2023, the Centers for Medicare & Medicaid Services (CMS) published their long-awaited proposed remedy to the unlawful 340B drug payment reductions. Background: In 2018, CMS significantly reduced the...more

McDermott+

McDermottPlus Check-Up: April 28, 2023

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Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

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​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

McGuireWoods Consulting

Washington Healthcare Update - May 2021 #2

This week in Washington: Biden Administration expresses support for WTO TRIPS Waiver....more

BakerHostetler

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

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With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

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On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Tucker Arensberg, P.C.

It Is Not Illegal to Pay Physicians More Than They Generate

While we are waiting for final disposition of the AKS Safe Harbors and Stark Exceptions proposed in October of 2019, since the comment period expired December 31, 2019 and final rules have not been issued, I thought we should...more

K&L Gates LLP

Triage in 2020: Health Care Topics to Watch in the New Year

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In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Foley & Lardner LLP

Price Transparency: Federal Government Issues Final Rule for Hospitals and Proposed Rule for Group Health Plans and Health...

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On November 15, 2019, the Federal Government issued two rules: one in final form and one in proposed form, both designed to increase price transparency in health care. The rules follow on the Executive Order announced by...more

King & Spalding

CMS Finalizes Rule to Require Hospitals to Disclose Negotiated Rates

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The Department of Health and Human Services (HHS), and the Trump Administration as a whole, has placed a particular focus on the promotion of price transparency as a tool to control the costs of healthcare. In June, the...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

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Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

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

Employers May Need to Provide Cost Data Under Proposed ACA Rules

Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more

Bass, Berry & Sims PLC

Trump Administration Proposes Transparency Rule for Group Health Plans and Insurers

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On November 15, 2019, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury (collectively, the Departments), unveiled a proposed rule (scheduled to be published on November...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

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On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that,...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...more

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