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.

New CMS Informed Consent Guidance for Sensitive Examinations of Unconscious Patients

Effective immediately, the CMS Guidance requires hospitals to ensure that medical professionals obtain and document the patients’ informed consent before sensitive examinations or invasive procedures.

Corporate Transparency Act: Reporting Requirements for Health Care Entities

To comply with the recent Corporate Transparency Act, owners and operators of a wide range of healthcare entities may be subject to report beneficial ownership information.

Update to Federal Substance Use Disorder Treatment Records Privacy Regulations – Part 2

The long-awaited federal Final Rule modifying the regulations that govern the privacy of substance use disorder treatment records remain stricter than HIPAA, especially regarding disclosures.

FTC, DOJ and HHS Launch Public Inquiry into Transactions Involving Private Equity Firms, Health Systems and Private Payers

the Federal Trade Commission, the Department of Justice’s Antitrust Division, and the Department of Health and Human Services announced that they were “launching a cross-government public inquiry into private equity and other corporations’ increasing control
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Estate Planning Essentials for Health Care Providers: Protecting Legacy and Loved Ones

Estate planning is especially important for healthcare providers who often have unique assets, liabilities and professional responsibilities.

New York Noncompete Ban Vetoed but Proposal Lives On

New York Governor Cathy Hochul recently vetoed a bill that would have enacted a sweeping ban on non-competition covenants.
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FTC/DOJ Merger Guidelines: Assessment of Rebuttal Evidence

Overall, the focus of this evidentiary review appears to be on whether the merger will produce substantial competitive benefits, i.e., will improve competition in the relevant market or prevent the threat that it may be lessened.
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Analysis: How the FTC and DOJ Final Merger Guidelines Impact on Health Care System Mergers

The merger guidelines will impact every health care system merger. In highly concentrated markets, a merger that eliminates a significant competitor creates significant risk that the merger may substantially lessen competition or tend to create a monopoly.
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New Annual Report Filing for PA Entities: What Should Businesses Consider?

PA entities and businesses should become familiar with the new annual reporting requirements and consider a few practical implications.
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2024 Brings Increased Scrutiny for Merging Health Care Firms

The Guidelines are intended to “reflect modern market realities, advances in economics and law, and the lived experiences of a diverse array of market participants.”
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How Do Personal Health Records Relate to HIPAA?

We delve into how Personal Health Records (PHR) differ from Electronic Health Records, key regulations affecting PHR, and how entities handling PHR approach compliance with the Health Insurance Portability and Accountability Act.
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Hospital at Home Programs Are Sticking Around

An analysis of the "Hospital at Home" program, its waivers and the key considerations for qualified hospitals that may want to pursue it.

New York to Decide on Signing Noncompetition Ban into Law

New York businessowners and employees alike await a decision from Governor Kathy Hochul as to proposed legislation, which has passed in both the New York State Senate and General Assembly, that would ban most non-competition covenants in the state.

U.S. Anesthesia Partners and Welsh Carson File Motions to Dismiss FTC Antitrust Case

In its complaint, the FTC alleges that USAP and Welsh Carson carried out a three-part plan to consolidate and monopolize the anesthesiology market in Texas.
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DOJ Drops No-Poach Criminal Case

This dismissal comes in the aftermath of the DOJ having previously lost four other criminal cases involving either no-poach or wage-fixing agreements.

Patients Suing Hospitals for Antitrust Violations – Do They Have Standing?

A recently decided case out of Connecticut provides a useful examination of how antitrust standing issues may be analyzed in cases involving commercially insured patients directly suing a health care system alleging economic harm.

OIG Issues General Compliance Program Guidance

This well-laid out reference guide will make life easier for compliance professionals and applies to all health care industry stakeholders.

Evading Transaction Roadblocks: Strategies for Common Late-Stage Dealbreakers

Late-stage transaction conflicts are not impassible and, if considered appropriately, can even result in an additional benefit to the Seller.

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

The OIG recently ruled that a proposed arrangement offering that required additional devices billed to federal health care programs would violate the federal Anti-Kickback Statute and the Beneficiary Inducements Civil Monetary Penalties Law.

Gag Clause Prohibitions in ERISA, the Internal Revenue Code and the Public Health Service Act

We examine the gag clause prohibitions affecting health plan contracts and related compliance processes and issues.
Doctor at Computer

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

The OIG recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the physician without violating the federal Anti-Kickback Statute.
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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.
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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.
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