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Medicare Medicare Part B Department of Health and Human Services (HHS)

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

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Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

Ballard Spahr LLP

Section 1557: Deadlines Approach, But Long-Term Prognosis Unclear Under Executive Orders

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Section 1557 of the Affordable Care Act mandates nondiscrimination in health care programs managed or funded by the Department of Health and Human Services (HHS), with upcoming deadlines for compliance set for May and July...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

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The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

King & Spalding

OIG Publishes the Fall 2024 Semiannual Report to Congress

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On December 4, 2024, OIG issued its fall 2024 Semiannual Report to Congress (the Report), which provides a comprehensive overview of the agency’s work completed during the reporting period of April 1, 2024, through September...more

Mintz - Health Care Viewpoints

Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model

On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more

Health Care Compliance Association (HCCA)

Privacy Briefs: September 2024

The HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

McCarter & English, LLP

Payment Flexibilities and New Legislation Introduced Regarding Healthcare Cyberattacks

For the past month or longer, many providers have reported a significant impact on their revenue cycle due to the cyberattack on Change Healthcare, LLC. In light of that impact, the Centers for Medicare & Medicaid Services...more

McDermott+

Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they...more

McDermott+

President Biden Releases FY 2025 Budget: What’s NOT in It?

McDermott+ on

Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more

McDermott+

Previewing the Final Hospital Outpatient Medicare Payment Reg

McDermott+ on

Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 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

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Holland & Knight LLP

Holland & Knight Health Dose: September 12, 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

Wiley Rein LLP

Medicare Drug Price Negotiation Program: Selected Drugs for 2026

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On Tuesday, August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) released the first ten prescription drugs selected for price negotiation with manufacturers (Selected Drugs) under the Inflation Reduction Act of...more

A&O Shearman

HHS selects the first drugs for Medicare drug price negotiation

A&O Shearman on

\On August 29, 2023, Health and Human Services (“HHS”) announced the first ten drugs covered by Medicare Part D selected for negotiation under President Biden’s Inflation Reduction Act of 2022 (“IRA”), which was signed into...more

Harris Beach Murtha PLLC

HHS Office of Inspector General Publishes August Work Plan Updates

In its August 15, 2023, Enforcement listserv notice, the U. S. Department of Health and Human Services Office of Inspector General (“OIG”) published its Work Plan Updates for August. This article will highlight three of the...more

McDermott Will & Emery

This Week in 340B: August 2023 #2

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

MoFo Life Sciences

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

MoFo Life Sciences on

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more

Alston & Bird

Health Care Week in Review: CMMI Model and IRA Part B Drug List

Alston & Bird on

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

Foley Hoag LLP

HHS Issues Report Outlining Three New Drug Models for Testing by CMMI

Foley Hoag LLP on

On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more

Foley Hoag LLP

OIG Technical Assistance on Part B Inflation Rebates Implementation Barriers and CMS’ Proposed Solutions in Recent Part B...

Foley Hoag LLP on

On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report entitled, “Technical Assistance Brief: Implementation of Inflation-Indexed Rebates for Part B Drugs.” ...more

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