Medicaid, Covered Entities, Department of Health and Human Services (HHS)

District Court Affirms Louisianas Protection of 340B Contract Pharmacy Arrangements

Morgan Lewis - As Prescribed on 10/21/2024

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

ArentFox Schiff on 6/27/2024

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

Proskauer - Health Care Law Brief on 6/24/2024

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on 9/15/2023

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

This Week in 340B: August 2023 #2

McDermott Will & Emery on 8/22/2023

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

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

Health Care Compliance Association (HCCA) on 8/8/2023

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

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

BakerHostetler on 8/8/2022

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

The 340B Contract Pharmacy Saga Continues

Foley Hoag LLP - Medicaid and the Law on 1/6/2021

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

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

K&L Gates LLP on 4/9/2020

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

McDermott Will & Emery on 2/5/2020

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

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

McDermott Will & Emery on 1/14/2020

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

OIG's List of Excluded Individuals/Entities – What Employers Need to Know

Baker Donelson on 4/22/2019

OIG maintains a list of all currently excluded individuals and entities called the "List of Excluded Individuals/Entities," or LEIE. Covered entities that hire – or continue to employ or work with – an individual or entity on...more

340B Update: HRSA Accelerates Implementation of Long-Delayed 340B Pricing and Manufacturer Penalties Rule

K&L Gates LLP on 11/5/2018

On October 31, 2018, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (“NPRM”) which proposes to move up the...more

Health-Related Facilities That Receive Federal Financial Assistance Now Required to Post Non-Discrimination Notices

Bond Schoeneck & King PLLC on 11/10/2016

Health-related facilities that receive Federal financial assistance (e.g., Medicare or Medicaid reimbursement) have been required to comply with Federal, as well as State, non-discrimination laws in the provision of services....more

HHS Final Rule Extends Anti-Discrimination Protection to Transgender Patients

Sheppard Mullin Richter & Hampton LLP on 8/5/2016

This past May, the Department of Health and Human Services (HHS) issued a final rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin,...more

New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have...

Sheppard Mullin Richter & Hampton LLP on 7/18/2016

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf. Individuals who are blind or have low vision may require assistive devices and specialized software to access the...more

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