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Medicaid › Medicare › 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 -
Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Polsinelli on

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Hogan Lovells

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

Hogan Lovells on

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

Proskauer - Health Care Law Brief

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

Proskauer - Health Care Law Brief on

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

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

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

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

McDermott Will & Schulte

This Week in 340B: August 2023 #2

McDermott Will & Schulte on

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

McDermott Will & Schulte

This Week in 340B: July 2023 #2

McDermott Will & Schulte on

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 on more than 40 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: June 2023 #4

McDermott Will & Schulte on

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 on more than 40 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: May 2023 #2

McDermott Will & Schulte on

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 on more than 40 340B cases to provide you with a quick...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

Foley Hoag LLP - Medicaid and the Law on

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

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

McDermott Will & Schulte on

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 18th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 16th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 11th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 9th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Hinshaw & Culbertson - Health Care

OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification Requirements

Hinshaw & Culbertson - Health Care on

On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. In addition to adopting new Covered Entity registration and recertification...more

K&L Gates LLP

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

K&L Gates LLP on

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

Baker Donelson

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

Baker Donelson on

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

K&L Gates LLP

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

K&L Gates LLP on

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

Bond Schoeneck & King PLLC

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

Bond Schoeneck & King PLLC on

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

Sheppard Mullin Richter & Hampton LLP

HHS Final Rule Extends Anti-Discrimination Protection to Transgender Patients

Sheppard Mullin Richter & Hampton LLP on

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

King & Spalding

OIG Report Examines Potential Scenarios for Restructuring 340B Program

King & Spalding on

Restructuring the 340B Drug Discount Program and Part B payment rules could reduce Medicare drug expenditures by up to $1.1 billion, the HHS Office of Inspector General (OIG) reported last week. The 340B Program requires...more

Sheppard Mullin Richter & Hampton LLP

States Take Aim At Health Insurance Providers Fee In New Litigation

Sheppard Mullin Richter & Hampton LLP on

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

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