News & Analysis as of

Medicaid Centers for Medicare & Medicaid Services (CMS) Covered Entities

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 -
Hogan Lovells

HRSA issues notice regarding 340B Rebate Model Pilot Program, limited to drugs subject to a maximum fair price (MFP) for 2026

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On July 31, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (Rebate Model Notice) announcing a 340B Rebate Model Pilot Program (Pilot Program). Notably, the Pilot...more

Venable LLP

Looming CTA Disclosure Requirements and Healthcare Providers

Venable LLP on

The Federal Corporate Transparency Act (the CTA), 31 U.S.C. §5336, will soon require certain entities to disclose to the U.S. Treasury's Financial Crimes Enforcement Network (FinCEN) certain pieces of identifying information...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

BakerHostetler

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

BakerHostetler on

​​​​​​​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

Fisher Phillips

Medicare and Medicaid Participants Face Sweeping New Workplace Vaccination Rule: A 5-Step Survival Guide

Fisher Phillips on

Note: This CMS Rule refenced in this Insight is separate and distinct from the OSHA ETS that was issued on November 4. Thus, although the CMS Rule could also be challenged in court, the November 6 court order blocking...more

Foley Hoag LLP - Medicaid and the Law

Supreme Court Will Hear Several Health Care Cases in 2022 Term

Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers.  We often write about the 340B program on our blog because of the...more

McDermott Will & Schulte

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more

K&L Gates LLP

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

K&L Gates LLP on

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

McDermott Will & Schulte

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

Sheppard Mullin Richter & Hampton LLP

States Take Aim At Health Insurance Providers Fee In New Litigation

Three states—Kansas, Louisiana and Texas—filed a complaint in federal court on October 22, 2015 challenging the constitutionality and legality of the Affordable Care Act’s health insurance providers fee. The health...more

Robinson & Cole LLP

Health Law Pulse - October 2015

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The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Ballard Spahr LLP

CMS Releases Final Rule on Physician Payment Disclosures

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Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more

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