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The 340B ‘Saga’ Continues: As More States Pass 340B Contract Pharmacy Laws, More Lawsuits Follow

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

Post-Chevron Health Care Regulations: The Dawn of a New Day

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more

FTC Rule Addressing Noncompete Covenants: Impact of Senior Executive Exception on Health Care Entities

The Federal Trade Commission’s (FTC) Final Rule banning noncompete covenants for workers is likely to present particular challenges for employers in the health care industry. Because of the structural and organizational...more

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

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

Emerging Opportunities for Hospitals in the Long Term Care Sector: Structuring Models and Key Considerations

Recent events have caused hospitals and health systems nationwide to contemplate more robust participation in the long term care (LTC) sector, whether through modified ownership, joint venturing, clinical affiliation, or...more

FTC Rule Addressing Noncompete Covenants: Impact on Individual Worker Agreements in the Health Care Industry

On May 7, the Federal Trade Commission (FTC) published a Final Rule banning noncompete covenants for workers, including employees, independent contractors, and volunteers. The Rule will have practical implications on worker...more

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more

Hospitality: 2023 Year in Review

As we enter the final quarter of 2023, the ArentFox Schiff Hospitality Industry group has identified several opportunities and challenges that could impact the hospitality industry, including issues related to artificial...more

Legislative Developments in AI: The Bipartisan Framework for the US AI Act

On September 12, 2023, the Senate Judiciary Subcommittee on Privacy, Technology, and the Law convened a hearing to discuss potential legislation focused on AI models, the third in a series of hearings by the subcommittee...more

OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more

AI’s Increasing Role in the Health Care Delivery System: Key Legal Considerations

No personal services are more important than health care. The use of artificial intelligence (AI), involving machines to perform tasks normally requiring human intelligence, is leading to an expansion of the term “personal.”...more

Telehealth Flexibilities Continue After End of COVID-19 Emergency

Telehealth experienced massive growth during the COVID-19 pandemic, due in no small part to various regulatory and reimbursement policies that federal agencies implemented following a declaration by the US Department of...more

FCC Provides Some Clarity On Healthcare Messages, Indirectly Confirms No Requirement To Use Free-To-The-End-User Texts

On January 23, 2023 the Federal Communications Commission’s (FCC) Consumer and Governmental Affairs Bureau released a Declaratory Ruling addressing a request for clarification submitted by US Department of Health and Human...more

OIG Warns Health Care Practitioners About Fraud Schemes With Telemedicine Companies in Special Fraud Alert

On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more

The Metaverse: A Legal Primer for the Health Care Industry

The metaverse is widely regarded as the next frontier in digital commerce, with businesses across all industries spending millions of dollars to acquire a digital presence for positioning as market leaders. While it offers...more

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more

HHS Asks FCC To Clarify TCPA Rules for Health Care Messages

Comments sought regarding the permissibility of messages relating to Medicaid and other health coverage programs. The FCC is seeking comment on a request for clarification submitted by the Department of Health and Human...more

OIG Issues Advisory Opinion Approving Biopharmaceutical Manufacturer’s Sponsorship of Free Genetic Testing and Counseling

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more

Triaging “Ivermania”: Recent Court Decisions Provide Guidance to Hospitals on Responding to Demands for Debunked COVID-19...

As the COVID-19 pandemic continues, hospitals and other health care providers are facing a separate challenge: “Ivermania”—the wave of lawsuits filed against hospitals by guardians of COVID-19 patients seeking court orders...more

FCC Seeks Reforms to Rural Health Care Program 

The FCC is requesting public comment on proposed reforms to the Rural Health Care Program to “promote program efficiency and ensure that rural healthcare providers receive appropriate levels of funding.” Initial Comments...more

2022 HOPPS Final Rule Addresses Hospital Price Transparency

New Rule Finalizes Penalties for Violating the 2021 Price Transparency Rule - On November 2, 2021, CMS published the 2022 Hospital Outpatient Prospective Payment System Final Rule that addressed its previously-proposed...more

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