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.

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2026 Deadline Looms for Compliance with Updated Part 2 Regulations Regarding Patient Data Protections

Part 2 is applicable to records related to the identity, diagnosis, prognosis or treatment of any individual in a federally assisted substance use disorder program.

Innovation and Privacy Protection: Managing Third-Party Risks in Data-Driven Health Care

Health care providers must examine their digital ecosystems carefully to ensure compliance, mitigate data risks and maintain public trust.
Metal wheels spinning

The OIG’s Seven Elements of an Effective Compliance Program

In a medical practice, building an effective compliance program means nurturing a culture of accountability and trust among all staff.

CMS Halts Survey and Certification Activities During the Federal Government Shutdown

The ongoing Shutdown is anticipated to significantly delay actions that require CMS certification and should therefore be taken into consideration when planning for any current or future projects.

When Compliance Becomes an M&A Dealbreaker: DOJ and OIG Guidance for Health Care M&A

Federal agencies have M&A in their sights as they continue to emphasize accountability, individual liability and program integrity in health care.

Expired Federal Telehealth Waivers: Key Changes in Medicare Reimbursement Requirements for Telehealth Providers

By remaining compliant with key telehealth delivery standards, telehealth providers can avoid or mitigate exposure from changes in reimbursement requirements from Medicare.
FTC Definition in a book

FTC and DOJ Issue Annual HSR Report Detailing Merger Review

We break down health care sector highlights and FTC merger enforcement actions reported in the 2024 fiscal year.
Metal wheels spinning

Enforcement of Prohibition on Interlocking Directorships Remains an FTC Priority

The FTC made clear its continued commitment to enforcing Section 8 of the Clayton Act, which prohibits directors and officers from serving simultaneously on the boards of competitors.
non compete agreement

FTC Sends Warning Letters to Health Care Organizations Regarding Legality of their Noncompete Agreements

The FTC encourages recipients to conduct a comprehensive review of their employment agreements to ensure that they comply with applicable laws.

FTC Ends Defense of Its Noncompete Ban and Announces Enforcement Initiatives    

The legality of noncompetes at the federal level will now be governed by the law as in effect prior to promulgation of FTC rule banning noncompetes.
Contract on table

Watching Your Back: Protections for Physicians in MSO Transactions

Physicians need to carefully scrutinize the documentation and framework surrounding a potential Management Services Organizations arrangements to limit risks.
Man on laptop

New York Adopts Certificate of Need Amendments to Streamline Reviews of Health Facility Projects

The amendments increase the overall total project cost thresholds that determine the level of review for projects and revise applicable review levels.
Researching finances

New Jersey’s Medical Debt Relief Act Now Fully in Effect

The Act protects patients from certain medical debt collection actions and contains several restrictions on medical debt collectors.
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Budget Negotiations May Delay Payments from the PA Department of Aging, DDAP, DOH or DHS

Human services organization or health-related entities that receives state funding may have payments delayed over the next six weeks.
Supreme Court

The Administrative State, a Three-Legged Stool, the Supreme Court and FCC v. Consumers’ Research

The case has broad applicability to federal regulatory agencies generally whenever Congress delegates authority to those agencies to implement federal law.

Another Step Toward Overruling Humphrey’s Executor and Granting Plenary Presidential Removal Authority

The order again portends that the Supreme Court will overrule or otherwise render dead Humphrey’s Executor — a decision that has assured the independence of the FTC.
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Pennsylvania House Bill Takes Aim at Private Equity in Health Care

HB 1460 would allow the PA Attorney General to review and potentially block mergers and acquisitions of health care entities involving private equity companies and other for-profit entities.
Metal wheels spinning

FTC Requests Additional 60 Days to Consider Dropping Defense of Noncompete Ban

The most recent request for the additional 60 days is based on the fact that the composition of the Commission has again changed.

New Changes to Medicare and Private Prior Authorization Processes

These changes aim to reduce the prevalence of fraud, waste and abuse in Medicare services and fix administrative inefficiencies for providers and patients.

HHS and DOJ Announce False Claims Act Joint Working Group and Identify Enforcement Priorities

These compacts will significantly streamline the process by which PA-licensed medical professionals can practice in other states, and vice versa.
doctor's white coat

Pennsylvania to Join Three Interstate Health Care Licensure Compacts

These compacts will significantly streamline the process by which PA-licensed medical professionals can practice in other states, and vice versa.

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.
stethoscope and money

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.
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