News & Analysis as of

Medicaid › Centers for Medicare & Medicaid Services (CMS) › Manufacturers

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -
Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

Latham & Watkins LLP on

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

McDermott Will & Schulte

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

McDermott Will & Schulte on

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more

Latham & Watkins LLP

Healthcare & Life Sciences Drug Pricing Digest - April 2025

Latham & Watkins LLP on

The Latham drug pricing and market access team invites you to read this digest of recent developments on healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Morgan Lewis

How the US Election May Affect Drug Pricing, Medicare, and Medicaid Programs – Key Areas to Watch

Morgan Lewis on

Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

Mintz - Health Care Viewpoints on

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Cozen O'Connor

Fourth Circuit Adopts Safeco Scienter Standard to Prove False Claims Act Violation in Legal Falsity Cases

Cozen O'Connor on

A few weeks ago, the U.S. Court of Appeals for the Fourth Circuit answered a critical inquiry in the False Claims Act (“FCA”) context: does a defendant violate the FCA when it’s reading of the regulation is objectionably...more

Foley Hoag LLP - Medicaid and the Law

CMS Reneges on Historic “Grand Bargain” with Manufacturers in Tennessee Wavier Approval

Foley Hoag LLP - Medicaid and the Law on

Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more

Hogan Lovells

Medicaid Drug Rebate Program: CMS addresses authorized generics, drug category narrow exception in manufacturer releases 112 and...

Hogan Lovells on

The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized generic drugs in the Average Manufacturer...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 1

K&L Gates LLP on

In Part One of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments that may affect drug pricing and pharmacy...more

Sheppard Mullin Richter & Hampton LLP

Years in the Making: The Health Resources & Services Administration Launches a Website to Increase Pricing Transparency in the...

Sheppard Mullin Richter & Hampton LLP on

If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

King & Spalding on

President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

Mintz - Health Care Viewpoints

President Trump Delivers Much Anticipated Drug Pricing Speech

Mintz - Health Care Viewpoints on

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more

Blank Rome LLP

New Medicaid Rebate Agreement

Blank Rome LLP on

On March 23, 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced the introduction of a new Medicaid National Drug Rebate Agreement. The new Agreement incorporates legislative and regulatory changes,...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

Foley & Lardner LLP

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Morgan Lewis

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

Morgan Lewis on

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Mintz - Health Care Viewpoints

The Countdown Begins – Sunshine Act Data Collection

Mintz - Health Care Viewpoints on

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers...more

The Volkov Law Group

CMS Issues Rules On Physician Payments Sunshine Act

The Volkov Law Group on

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

27 Results
 / 
View per page
Page: of 2
Next »

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide