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.

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.

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.

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.
Covid Vaccines Legal statue

The End of the Public Health Emergency: Updated Guidance

The Public Health Emergencyarising from the COVID-19 pandemic will officially end May 11, 2023. The Biden administration will attempt to advance a number of priorities that resulted from COVID-19.
child in therapy

Navigating Parent Notifications When Minor Consents to Outpatient Behavioral Health Treatment in PA

In the context of a minor patient’s consent to inpatient behavioral health treatment, Pennsylvania law and regulations address parental notice and objection rights, but it is not so clear in the outpatient context.
nursing home

Change of Ownership Regulatory Changes for PA Long-Term Care Facilities

Effective February 1, 2023, the DOH issued a “notice and opportunity to comment” on a new regulation for LTC facilities that plan to undergo a change in ownership.
Stethoscope on Money

Proposed NY Legislation Requires DOH Approval of Health Care Entity Transactions

Passage of the Bill would vest substantial authority in the DOH to scrutinize Material Transactions and apply additional, material conditions on Health Care Entities that wish to consummate covered transactions.
Mergers and Acquisitions

U.S. DOJ Announces Withdrawal of Health Care Market Policy Statements

Providers should adjust merger plans and advocacy to recent DOJ enforcement actions rather than "outdated" statements.
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.
puzzle with new piece

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.