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.

Pharmacy Drugs

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The Superior Court of New Jersey, Appellate Division, upheld in an unpublished opinion that a medical practice may not own an in-practice pharmacy to which the physician owners refer patients.
gavel and stethoscope

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.
Pile of Medical Bills

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

Handling PHI requests from third parties is commonplace. However, it can be a bit intimidating to get a subpoena seeking PHI — not least given the subtle threat in the word itself.
Chat Bot on a Cellphone

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 health care 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.
two cities as puzzle pieces merging together

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.
reports with magnifying glass

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.
lightbulbs hanging

Comment Opportunity: FTC and DOJ Request Input on Mergers and Acquisitions

This Request provides an opportunity for the health care sector to provide comments to the FTC and DOJ.
paper says payroll tax next to calculator

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.
Stethoscope on Money

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.
compass laying on blueprints

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.
notepad on a boardroom table

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.
patients visiting doctor on laptop

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.
doctor in goggles and mask

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.   
Dollar Sign Bag with Stethoscope

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.
stethoscope laying on a book

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.
doctors looking at tablet

New Laws Expand the Autonomy of Physician Assistants in Pennsylvania

Governor Tom Wolf signed five new bills into law, including legislation that provides for permanent COVID-19 waivers that will give physician assistants more leeway and autonomy to practice in Pennsylvania.
medical records folders

OCR Issues HIPAA and COVID-19 Vaccination Guidance

The Office for Civil Rights recently released guidance on HIPAA’s application to an individual’s COVID-19 vaccination status.
President Biden’s COVID-19 Action Plan and Private Employers

President Biden’s COVID-19 Action Plan and Private Employers

On September 9, 2021, President Joe Biden announced a six-pronged COVID-19 Action Plan.
doctor holding swab and testing tube

Delaware Advances COVID-19 Vaccination Requirements for Health Care And State Employees

Delaware Governor John Carney ordered all state employees and health care workers to be vaccinated for COVID‑19 on or before September 30 or submit to regular COVID-19 testing.
hospital bed in hospital room

Legislation Aims to Regulate Nurse-to-Patient Ratios in Pennsylvania

Pennsylvania State Senator Maria Collett recently announced the reintroduction of the Patient Safety Act to help set safe nurse-to-patient ratios in Pennsylvania – a problem that has been exacerbated by COVID-19.