Health Law Observer

Timely insights and legal commentary on various health care issues and developments surrounding regulations, employment, transactions and a range of key industry matters. This blog is maintained by the Health Care Department of Stevens & Lee.

non compete agreement

FTC’s Proposed Non-Compete Ban: What Prior Decisions and Guidance May Reveal About the Impact on Nonprofit Healthcare Providers

New Jersey’s “Change of Ownership” (CHOW) requirements in health care transactions span a range of employment, employee benefits and notification obligations.
Stethoscope on Money

Reminder: NJ “Change of Ownership” Requirements for Health Care Transactions Have Changed

New Jersey’s “Change of Ownership” (CHOW) requirements in health care transactions span a range of employment, employee benefits and notification obligations.
non compete agreement

FTC Proposed Non-Compete Ban: Impact on Nonprofit Hospitals and Nonprofit Affiliates

Cross-market mergers have received increased attention among health care economists and lawyers and as of late have received the increased interest of the enforcement agencies.

New OIG Opinion Permits the Provision of Free Nurse Practitioner Services by a Hospital to Referring Physicians

Under certain parameters, professional and administrative services outside of those covered by Anti-Kickback Statute safe harbors can be provided for free to referring physicians.
non compete agreement

FTC Proposes Banning and Rescinding Worker Non-Competes

If finalized, this non-compete ban would have a monumental impact on the health care industry, among numerous others.
Doctor at Computer

Biden Administration Proposes New Religious Conscience Rule for Health Workers

The Proposed Rule focuses on strengthening protections for health care workers with conscience or religious freedom complaints without sacrificing access to a range of necessary services.

Federal Case Details How a Relator-Whistleblower Satisfies the False Claims Act’s “Original Source” Requirement

Cross-market mergers have received increased attention among health care economists and lawyers and as of late have received the increased interest of the enforcement agencies.
Pile of Medical Bills

Medicare Implications of the Omnibus Spending Bill

FDA guidance for veterinarians, state-licensed pharmacies and federal facilities regarding compounding animal pharmaceuticals will take effect April 2023.
Pharmacy Drugs

FDA Guidance on Drug Compounding for Veterinarians and Pharmacists

FDA guidance for veterinarians, state-licensed pharmacies and federal facilities regarding compounding animal pharmaceuticals will take effect April 2023.
scales of justice with american flag background

Continued Spotlight on Cross-Market Hospital Mergers

Cross-market mergers have received increased attention among health care economists and lawyers and as of late have received the increased interest of the enforcement agencies.
Updated FAQ on Corporate Integrity Agreements Details Obligations for Reportable Event Disclosures

HHS Proposes Updates to “Part 2” Regulations on Substance Abuse Record Confidentiality

Proposed changes to Part 2 include updates to consent requirements, redisclosure permissions, patient rights, enforcement and others.
gavel on a keyboard

The Supreme Court Hears Oral Argument in Axon v. FTC

Following oral arguments in Axon v. FTC, numerous questions and comments by the Court indicate that it may ultimately side with the petitioners.
person looking at medical information on iphone

Pennsylvania Permanently Allows Audio-Only Behavioral Health Services

House Bill 1630 made permanent the relaxation of regulatory requirements regarding telehealth behavioral health services provided on an “audio-only” basis.
gavel and stethoscope

2022 Guidance on No Surprises Act Compliance

We examine numerous updates and changes regarding the No Surprises Act (NSA) and the subsequent compliance implications.
Mergers and Acquisitions

Challenging the Constitutionality of the FTC’s Fundamental Structure/Processes

Health care providers and others in health care contemplating merger and other transactions subject to FTC review should be ready for significant implications arising from Axon Enterprise, Inc. v. Federal Trade Commission.
Stethoscope on Money

Selling Your Health Care Practice? Consider Timing and Effort Before Saying “Yes”

For a number of reasons, the calendar is among most effective tools for advancing a transaction from “potential transaction” to a “closed transaction.”

Is PA Getting Closer to Eliminating Noncompetes for Health Care Practitioners?

New legislation is intended to help retain health care practitioners in the Commonwealth and maintain continuity of care.
Outline of Certain Tax Reform

Expanding Support for Pediatric Mental Health Care

President Biden has prioritized strengthening and expanding the Pediatric Mental Health Care Access Awards program, according to the Secretary of the United States Department of Health and Human Services.
two cities as puzzle pieces merging together

Dissolving a New York Not-For-Profit Corporation Without Assets

Many of the steps are straightforward and expected, but it is important that you understand the commitment of time necessary to finally get that receipt from the NY Department of State that the entity is officially dissolved.
Mergers and Acquisitions

COPA-Like Agreements in Pennsylvania and COPA Rules in Neighboring States

We examine COPA-like agreements in Pennsylvania where health systems seeking to merge as well as a COPA rules in neighboring states.
FTC building

Federal Trade Commission Policy Paper Takes Hard Stance Against Certificates of Public Advantage

In the recently issued Policy Paper and based in part on the empirical evidence that it gathered, the FTC vigorously disputes the claimed justifications for COPAs.
Mergers and Acquisitions

Possible Changes to the 2010 Merger Guidelines Regarding Pro-Competitive Efficiencies

The questions posed by the Agencies serve as a useful roadmap for hospital systems considering a merger and addressing the issue of pro-competitive benefits.
Test Tubes for Clinical Trial

FDA Working to Encourage Diversity and Equity in Clinical Trials 

The FDA has recently made efforts to encourage more diversity and equity in clinical trials by releasing “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” 
Pile of Medical Bills

Federal Judge Throws Out Yet Another Portion of “Surprise” Medical Billing Rule

Judge Jeremy Kernodle of the U.S. District Court for the Eastern District of Texas decided to throw out another portion of the “No Surprise Act” in Lifenet, Inc., v. United States Department of Health and Human Services
Close