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.

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.
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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.
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 Marble Palace

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.

Two Recent Federal Court Cases Tackle Three Critical Components of the Anti-Kickback Statute

Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute.
reports with magnifying glass

FY 2024 Proposed Medicare Reimbursement Changes for Certain Nursing and Inpatient Facilities

Centers for Medicare & Medicaid Services issued a number of proposed rules that would materially impact reimbursement rates for skilled nursing facilities (SNFs), inpatient psychiatric facilities (IPFs) and inpatient rehabilitation facilities (IRFs).
business people meeting with physician

How to Comply with the Stark Law when Recruiting a Physician

This overview spotlights key details about avoiding federal Stark Law violations when a hospital needs to recruit more physicians to their area.
courtroom

Public Disclosure Bar Applies – Court Dismisses Whistleblower’s False Claims Complaint

A recent U.S. District Court decision provides a good example of how federal courts will apply the public disclosure/original source rules in whistleblower cases alleging that health care providers violated the False Claims Act.
national emergency

The End of the Stark Law Blanket Waivers: What Do Providers Need to Do Now?

Since the Stark Law is a strict liability statute, with significant civil penalties for violations, this immediate compliance requirement should be noted by parties currently relying on a blanket waiver to protect an arrangement.
Stethoscope on Money

Practical Considerations of New NJ/NY Health Care Transaction Requirements

Parties to a covered transaction would be well-advised to develop strategies to predict and avoid pitfalls, in addition to assuring compliance with legal requirements. We examine Key workforce, logistical and messaging considerations.
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