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.

HIPAA Final Rule on Reproductive Health Care Privacy Struck Down

U.S. District Court vacates HHS’ Final Rules modifications of HIPAA regulations related to reproductive health care privacy.
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Navigating Interstate Entity Issues: Corporate Practice of Medicine and Ownership Considerations

Proactively analyzing corporate practice of medicine and ownership requirements can reduce legal issues when commencing operations in new markets.
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CMS Issues Updated Hospital Price Transparency Guidance and Related RFI

CMS released new guidance, and asked for input, on standards to bolster the transparency of pricing for hospital services and items.

Has Humphrey’s Executor Been Effectively Overruled on the Supreme Court’s Emergency Docket with Impact on the FTC?

This decision will have a major impact on how FTC and federal antitrust laws are applied to health care providers.

NY Department of Health Provides Guidance Regarding Material Transactions Law

Certain health care entities involved in a transaction that increases gross, in-state revenue to at least $25 million must provide written notice of the transaction to the NY Department of Health

U.S. Supreme Court Readies to Decide an Important Separation of Powers Issue

We reexamine oral arguments and issues surrounding a case that could dramatically change how Congress may empower regulatory agencies to promulgate regulations and fund and operate their programs.

Presidential Memorandum Calls for Scrutiny and Fast-Track Repeal of Regulations

This review-and-repeal effort prioritizes the evaluation of the lawfulness of existing regulations in light of 10 recent U.S. Supreme Court decisions.
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FTC Launches Public Inquiry – Anticompetitive Regulations on the Chopping Block

The RFI invites public comment on issues or concerns regarding regulations that can operate to exclude new market participants, protect dominant incumbents and predetermine economic winners and losers.
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DOJ Launches Task Force to Identify and Eliminate Anticompetitive Laws and Regulations

The formation of the Task Force comes just weeks after the Commission issued guidelines explaining how it will assess whether business practices affecting workers violate the antitrust laws.
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Standards Loosened for PA First Responders to Claim Workers’ Compensation for Post-Traumatic Stress Injury

Organizations employing qualified first responders should remain mindful of the upcoming change and be prepared to address claims arising from qualifying traumatic events.

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

Medicare, Medicaid and other federal health care program providers and suppliers can anticipate changes and potential delays in regulatory, enforcement and compliance actions.

Can Pennsylvania Certified Registered Nurse Practitioners Own a Medical Practice Solo?

While certain laws and regulations do not expressly permit a CRNP to own and operate their own medical practice, they do leave open enough room for a CRNP to do so.

New Labor Task Force to Investigate and Prosecute Unfair and Anticompetitive Labor Market Conduct

The formation of the Task Force comes just weeks after the Commission issued guidelines explaining how it will assess whether business practices affecting workers violate the antitrust laws.
Rural Emergency Room

Urgent Care Centers Must Now Comply With Pennsylvania Newborn Safe Haven Law

Urgent care centers must now accommodate Pennsylvania's Newborn Protection Act through policies, training and updates to its premises.
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Federal Court: No Sherman Act Violation Absent Anticompetitive Conduct and Anticompetitive Effects

Notably, this case emphasizes that claims alleging anticompetitive conduct must show anticompetitive harm, not just intent behind the conduct.

First Circuit Rules Against Government in False Claims Act Case

The ruling in this case makes it more difficult for the government or whistleblower to prove a False Claims Act violation in the presence of an Anti-Kickback Statute violation and to recover damages.
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Higher Prices, Reduced Access, Lower Quality Care: HHS, FTC, DOJ Report Harshly Criticizes Provider Consolidation and Private Ownership

A report was issued regarding an RFI seeking public comment on transactions involving health care providers, facilities or ancillary products or services.

FTC Settlement Proposes Consent Order to Monitor Private Equity Firm Welsh Carson’s Acquisitions Plans

The FTC’s proposed Consent Order would have Welsh Carson give advance notice prior to pursuing transactions involving anesthesia businesses and hospital-based physician practices nationwide.

Planning for 2025: Track Your Post-Closing Obligations for Health Care Transactions

We outline common post-closing items that former owners and their advisors should consider as they develop plans and strategies for 2025.
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FTC Files Opening Brief in Noncompete Rule Appeal

In its brief, the FTC asserts that the Federal Trade Commission Act grants it authority to issue substantive rules defining unfair methods of competition, including the ban on noncompetes.

Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

It is imperative that HCPs, MAOs, agents, brokers and others carefully structure their relationships to ensure compliance with federal laws.

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

Compliance requires not just a review of the Final Rule, but revised policies and procedures, updated personnel training and effective implementation.

DOJ and FTC Withdraw Guidelines for Collaborations Among Competitors

In their assessments, FTC commissioners explained the Guidelines relied on outdated policy statements and analysis and risked creating unwarranted safe harbors.
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New Jersey Expands Hospital at Home Program

The CMS Acute Hospital Care at Home Individual Waiver allows hospitals to provide care to certain patients in their homes. Earlier this year, New Jersey passed legislation to expand this program.
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