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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OIG Anti-Kickback Opinion Examines Physician Ownership of Medical Device Manufacturer and Referrals

OIG issued Advisory Opinion 22-07 delves into whether physicians who have an ownership interest in a medical device company are at risk for anti-kickback sanctions
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Bipartisan Mental Health Legislation Awaits House Vote

Legislation includes provisions that address mental health concerns in children and focus on expanding access to mental health care

Policy Considerations for Voice-Controlled Devices Used in Senior Care Facilities

We examine key privacy rights considerations as well as best practices for shaping effective policies for voice-controlled device usage in senior care settings.
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How Does the Third Circuit Analyze Hospital Mergers?

We examine how the FTC and courts such as the Third Circuit currently analyze proposed hospital mergers.
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Key Issues in Direct Health Care Contracting with Employers

We examine a list of some high-level questions for health care providers to consider when directly contracting with employer plans.
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NJ Codey Law Updates – The End of the In-Practice Pharmacy?

The Superior Court of New Jersey, Appellate Division, upheld in an unpublished opinion that a medical practice may not own an in-practice pharmacy to which the physician owners refer patients.
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PA Department of Health Defines Factors and Uses for “Innovative Hospital Models”

There is now a clear understanding what a hospital must do to operate Micro-Hospitals, Outpatient Emergency Departments and Tele-Emergency Departments.
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Federal Judge Throws Out Portions of “Surprise” Medical Billing Rule

A federal judge in Texas threw out parts of the No Surprises Act rule that established the arbitration process supported by Congress meant to protect patients from surprise medical bills.
Updated FAQ on Corporate Integrity Agreements Details Obligations for Reportable Event Disclosures

HIPAA Privacy Rule May Allow Stopgap to Subpoenas That “Order” Personal Health Information

As life science companies begin to leverage technologies, they must balance the use of healthcare provider engagement technologies, like chat bots, with certain risks.
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Chat Bots in the Life Sciences – Engagement Opportunity or Compliance Liability?  

As life science companies begin to leverage technologies, they must balance the use of healthcare provider engagement technologies, like chat bots, with certain risks.
Immigration Solutions for Today's Workforce

H-1B Fiscal Year 2023 Is Here

For Fiscal Year 2023, H-1B electronic registration for employers will open at noon EST on March 1, 2022, and run through noon EST on March 18.
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Key Takeaways: CMS’s Final Guidance on Hospital Co-Location

On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued final co-location guidance for hospitals and other health care facilities.
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Delaware Primary Care Update

Updates emphasize the need for greater participation in alternative payment models, increased utilization of value-based payment, and cost containment driven by primary care investment.
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Comment Opportunity: FTC and DOJ Request Input on Mergers and Acquisitions

This Request provides an opportunity for the healthcare sector to provide comments to the FTC and DOJ.
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LLCs Remain a Strategic Option for Tax-Exempt Health Care

A recent IRS notice has reinvigorated the discussion around utilizing limited liability companies (LLCs) in connection with Section 501(c)(3) tax-exempt organizations.
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It’s 2022 — Are You Ready for Group Practice Changes?

Group practices gain notable opportunities in distributing Designated Health Services (DHS) profits and productivity bonuses.
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Infrastructure Deal Includes Grants for Nonprofits to Make Energy-Efficient Upgrades

The Act specifically contemplates the installation of materials on buildings that reduce the building’s use of fuel and other energy.
Updated FAQ on Corporate Integrity Agreements Details Obligations for Reportable Event Disclosures

Updated FAQ on Corporate Integrity Agreements Details Obligations for Reportable Event Disclosures

The Corporate Integrity Agreements FAQ clarifies which disclosure protocols suit certain Reported Events.
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OIG Self-Disclosure Protocol: Some Things Change; Some Stay the Same

On November 8, 2021, the OIG updated and renamed its “Provider Self-Disclosure Protocol” to the “Health Care Fraud Self-Disclosure Protocol” applicable to disclosure of certain non-compliance with the federal Anti-Kickback Statute.
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Upcoming Sunset of Regulatory Suspensions and Clarifying Guidance – Submit Pennsylvania Telehealth Behavioral Health Waiver Requests Before the Deadline

The Pennsylvania Department of Human Services, Office of Mental Health & Substance Abuse Services (OMHSAS), issued Frequently Asked Questions (FAQs) to clarify its recently revised Behavioral Health Telehealth Policy Guidance.
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CMS Emergency Regulations Mandate COVID-19 Vaccination of Certain Health Care Workers

CMS issued a press release that announced the availability of the display copy of the anticipated Interim Final Rule on COVID-19 Health Care Staff Vaccinations.
OSHA Issues COVID-19 Vaccination and Testing Emergency Temporary Standard

OSHA Issues COVID-19 Vaccination and Testing Emergency Temporary Standard

We provide answers to some of the most common questions concerning the ETS.   
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FTC Policy Change May Signal Increased Scrutiny for “Anticompetitive” Health Care Transactions

Organizations subject to a consent order or other FTC order will now be required to provide prior notice to, and obtain prior approval from, the FTC for applicable future transactions.
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Pennsylvania House Demands Transparency for Population Health Data

The Pennsylvania House of Representatives recently passed HB 1893 to amend Section 15 of the Pennsylvania Disease Prevention and Control Law.
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