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.

federal trade commission building

FTC Abandons Axon Challenge Following Supreme Court Loss

With the fact that the constitutional challenges to its structure/processes would now be adjudicated by a district court, the FTC announced it was dropping its case.

U.S. Supreme Court Declines to Clarify Key Provisions of the False Claims and Anti-kickback Statutes

The U.S. Supreme Court denied the request of qui tam relators that it review the Sixth Circuit’s decision in a recent case resulting in an unregistered meaning for both Anti-kickback Statue and False Claims Act.
Judge gavel & doctor with stethoscope intertwining

Louisiana’s COPA Exempts Hospital Acquisitions from Federal Antitrust Laws

The District Court for the District of Louisiana recently issued an order granting motions for summary judgment in favor of a notable hospital merger, holding that Louisiana’s issuance of a COPA constituted state action.

False Claims Act’s Materiality Requirement Spotlighted Again in Recently-Decided Third Circuit Case

The False Claims Act’s materiality requirement as articulated by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel. Escobar, 579 U.S. 176 was again front and center in a case decided by the Third Circuit Court of Appeals.
Anesthesiologists preparing to put a patient under.

FTC Sues Private Equity Firm and Anesthesia Group Alleging Unlawful Monopolization in Texas Market

The FTC filed suit alleging that U.S. Anesthesia Partners, Inc. and the private equity firms, creating USAP, executed a multi-year anticompetitive scheme to consolidate anesthesiology practices in Texas to drive up prices in order to boost their own profits.
stethoscope on book

Draft Merger Guidelines: Rebutting a Claim of Substantial Lessening of Competition

We discuss rebuttal evidence that merging parties may offer to show that no substantial lessening of competition is threatened by the proposed merger.
Mergers and Acquisitions

FTC/DOJ Announce Three Public Workshops to Discuss the Draft Merger Guidelines

The workshops are aimed at promoting a “dynamic discussion” about the draft guidelines to complement the comments currently being submitted.
Operating Room Technology

OIG Says Proposed Surgery Monitoring Arrangement May Violate Kickback Statute

The OIG opinion is significant in that it again illustrates how the OIG may treat business arrangements with characteristics of a contractual joint venture as prohibited arrangements.

Do New Jersey Regulations Require Assisted Living Residence Admission Agreements to Contain Certain Language?

This post walks through a few of the requirements for the resident’s written agreement upon admission to a New Jersey assisted living residence.
Healthcare Merger representation

Details on the 2023 DOJ and FTC Proposed Merger Guidelines’ Potential Impact on Health Care Systems

This post provides additional detail as to how some of the 13 specific guidelines in the Proposed Guidelines are likely to be applied by the Agencies, especially as they are likely to impact mergers involving health care systems.
Doctor with physician burnout

New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout

These efforts aim to permit health care entities to provide wellness programs to assist physicians and other clinicians seeking help for their mental health.
Rules and regulations book. Law, rules and regulations concept. 3d illustration

FTC and DOJ Issue Proposed Updated Merger Guidelines

The DOJ and FTC jointly issued a draft update of their Merger Guidelines intended to describe and guide the Agencies’ review of mergers and acquisitions to determine compliance with federal antitrust laws.
Mergers and Acquisitions

FTC Follows DOJ and Withdraws Antitrust Policy Statements

The Federal Trade Commission announced that it was withdrawing two antitrust policy statements related to enforcement in health care markets.
Elderly Couple Behavioral Health

PA House Passes Bill to Mandate Patient-to-Nurse Staffing Ratios

The Patient Safety Act proposes specific patient-to-nurse staffing ratios, staffing plans and reporting requirements for Pennsylvania hospitals, as well as protections for nurses in noncompliant hospitals.
nursing home

New Jersey’s First Hospital-Based Supportive Housing Opened Via Pioneering State Partnership Program

Barclay Place is a 56-unit housing community where supportive services are offered by St. Joseph’s Health.
columns of historic building

Supreme Court’s Decision in SuperValu May Benefit Defendants in False Claims Act Cases

The Court may have opened a door to what will ultimately become intense disagreement between the Government and relators on the one hand and FCA defendants on the other as to the meaning of the term “knowingly” as used in the FCA.
two cities as puzzle pieces merging together

FTC Calls for Major Changes in Hart-Scott-Rodino Rules

The Federal Trade Commission on June 27 issued a proposed rule pursuant to which it would amend its Hart-Scott-Rodino Act form and instructions and in so doing make major “top-to-bottom” changes for the first time in 45 years.

Is Fair Market Value Dispositive in an Anti-Kickback Statute Case?

The key question is a burden of proof question because it involves the definition of the term “remuneration,” without which there can be no AKS violation.

Supreme Court Grants Government Broad Dismissal Rights in Qui Tam Cases

In a unanimous decision, the U.S. Supreme Court ruled that the False Claims Act’s scienter element refers to a defendant’s knowledge and subjective beliefs — not to what an objectively reasonable person may have known or believed.
vials of covid-19 vaccine

Final Rule Ends COVID Vaccine Mandate in CMS-Certified Facilities

The Final Rule addresses three Interim Final Rules with Comment implemented during the COVID-19 Public Health Emergency.

Supreme Court Rules Knowledge and Subjective Belief Are Key for False Claims Act Liability

In a unanimous decision, the U.S. Supreme Court ruled that the False Claims Act’s scienter element refers to a defendant’s knowledge and subjective beliefs — not to what an objectively reasonable person may have known or believed.
magnifying glass and calculator

New York Enacts Notice Requirements for Material Health Care Transactions but Removes Approval Authority

The Amendment was enacted as a measure in response to private equity investment in health care and to address a perceived lack of oversight and regulation of private investment in Healthcare Entities.
gavel and stethoscope

Federal Court Grants Medical Center’s Request for Transfer of FTC Suit

On May 23, the D.C. District Court issued an order granting LCMC’s request to have the case transferred.
medical spa bed and room

CMS Final Rule: Medicare Advantage Plans Subject to Two-Midnight Coverage Condition

Regarding inpatient admissions specifically, CMS’ Final Rule confirms that the two-midnight condition set forth in the traditional Medicare regulations applies likewise to MA coverage requirements.