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 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 firm Welsh, Carson, Anderson & Stowe, which created USAP, executed a multi-year anticompetitive scheme to consolidate anesthesiology practices in Texas, drive up the price of an
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.
magnifying glass and calculator

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 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.
two cities as puzzle pieces merging together

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

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.
Stethoscope on Money

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.
gavel

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.

Sixth Circuit Denies Rehearing in Hospital-Physician Kickback Case

The Sixth Circuit issued an order denying the request for a rehearing of a case involving a hospital’s decision not to hire an ophthalmologist in return for a general commitment of continued surgery referrals from another ophthalmologist.
Covid Virus

CMS Guidance on the Expiration of the Public Health Emergency

On May 1, CMS issued guidance regarding the May 11 expiration of the COVID-19 public health emergency.
puzzle with new piece

FTC Sues to Compel State-Approved Hospital Acquisitions to Comply with Hart-Scott-Rodino Act Requirements

While it anticipated that LCMC and HCA will file motions requesting that the FTC’s case be transferred to the Eastern District of Louisiana, it is not clear at this juncture which court will ultimately adjudicate the pending suits.

Supreme Court Unanimously Rules in Favor of Axon: Challenges to Constitutionality of FTC Structure/Process May Proceed in Federal Court

Axon is now free to immediately pursue its constitutional challenges to the FTC processes/structure, the implications of which are significant to the health care industry.
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