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Drug Pricing › Compliance › Medicaid

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

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

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

Health Care Compliance Association (HCCA)

340B Drug Pricing Program Compliance

Health Care Compliance Association (HCCA) on

The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount. In this podcast, Jason...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Foley Hoag LLP - Medicaid and the Law on

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Holland & Knight LLP

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

BakerHostetler

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Baker Donelson

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

Baker Donelson on

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

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