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Centers for Medicare & Medicaid Services (CMS) Prescription Drugs

Mintz - Health Care Viewpoints

Stakeholders Raise 340B Concerns in Medicaid Drug Rebate Program Final Rule; CMS, With Hands Tied, Shrugs

On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders...more

Alston & Bird

Health Care Week in Review: HHS Released Proposed Rules Enhancing Coverage of Preventive Services; OIG Released Report on...

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

Latham & Watkins LLP

Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit

Latham & Watkins LLP on

Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado...more

Morgan Lewis - Health Law Scan

CMS Announces Updated List of Drugs Under the Inflation Rebate Program

Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its...more

Alston & Bird

Health Care Week in Review: HHS Announced Updates on Response to IV Fluid Shortage and 233 Members Call on House Leadership to...

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

Venable LLP

Accord BioPharma’s Stelara® Biosimilar Imuldosa™ Approved by FDA

Venable LLP on

On October 10, 2024, the FDA approved Accord BioPharma’s Imuldosa™ (ustekinumab-srlf), the fifth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa™ was developed by Dong-A ST in collaboration with...more

Manatt, Phelps & Phillips, LLP

CMS Releases Final 2027 IRA Negotiation Guidance

On October 2, the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining how the agency will implement the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (the “Program”) for...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2024 #2

News Briefs - 75% of Hospitals Spending More on Tech to Boost Cybersecurity - Three-quarters of hospitals and health systems spent more on information technology last year and many will continue to do so, with greater focus...more

Alston & Bird

Health Care Week in Review: CMS Publishes 2025 MA and Part D Star Ratings and Releases RFI on Medicare $2 Drug List Model

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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

Benesch

Dialysis & Nephrology Digest - October 2024

Benesch on

The House Ways and Means Committee has postponed discussions on several healthcare bills, including those related to physician pay, due to scheduling conflicts and disagreements over legislative language. This delay affects...more

Hogan Lovells

CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

Hogan Lovells on

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

Foley & Lardner LLP

Medicare: Prescriptions Now May Be Used to Support Medical Necessity of Durable Medical Equipment

Foley & Lardner LLP on

On September 26, 2024, the Centers for Medicare & Medicaid Services’ (CMS) Durable Medical Equipment (DME) Medicare Administrative Contractors (DME MACs), Noridian Healthcare Solutions, LLC and CGS Administrators, LLC,...more

Alston & Bird

Health Care Week in Review: Congress Passed a Continuing Resolution (CR); CMS Released Guidance on Coverage Requirements for...

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

Venable LLP

REMINDER: October 15 Is the Deadline for Prescription Drug Notices and the Extended Deadline for Form 5500s

Venable LLP on

Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2024 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more

Latham & Watkins LLP

Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry

Latham & Watkins LLP on

Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

Hogan Lovells

CMS issues Final Rule adopting some but not all proposed changes to the Medicaid Drug Rebate Program

Hogan Lovells on

On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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 & Lardner LLP

The 340B Drug Pricing Program: Top Five Things to Know

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The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...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

Goodwin

The Centers for Medicare & Medicaid Services Announces Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation

Goodwin on

As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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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

Venable LLP

2025 Changes to Medicare Part D Will Impact Group Health Plans' Creditable Coverage Determination

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The Inflation Reduction Act of 2022 made significant design changes to Medicare Part D effective January 1, 2025. The changes will cause an increase in the actuarial value of Medicare Part D coverage, which will impact...more

Cooley LLP

US CMS Announces Initial Prices for Medicare Drug Price Negotiation Program

Cooley LLP on

On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #4

News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more

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