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.[1]  The guidance was immediately effective and provided clarity with respect to how such health care facilities can work collaboratively to provide care at a single location.  The initial co-location guidance was issued on May 3, 2019.  A link to the final guidance is located here. Key takeaways from the final guidance include: Medicare conditions of participation permit hospitals to co-locate with other hospitals and other health care providers and share certain common space within the same building or campus. Co-location occurs...

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OIG Self-Disclosure Protocol: Some Things Change; Some Stay the Same

On November 8, 2021, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) updated (for the first time in years) and renamed its “Provider Self-Disclosure Protocol” to the “Health Care Fraud Self-Disclosure Protocol” (SDP) applicable to disclosure of certain non-compliance with the federal Anti-Kickback Statute (AKS).

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Upcoming Sunset of Regulatory Suspensions and Clarifying Guidance – Submit Pennsylvania Telehealth Behavioral Health Waiver Requests Before the Deadline

On October 29, 2021, 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. In addition to issuing the FAQs, OMHSAS reminded providers that when PA Act 73 of 2021 sunsets (currently anticipated to be March 31, 2022), providers will need to have an approved waiver in their possession to continue to provide certain behavioral health services by telehealth. PA Act 73 of 2021 extended regulatory waivers granted in response to the COVID-19 emergency without requiring providers to submit and be in possession of an approved...

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OSHA Issues COVID-19 Vaccination and Testing Emergency Temporary Standard

The federal Occupational Safety and Health Administration (“OSHA”) took the unprecedented step of issuing an Emergency Temporary Standard (“ETS”) requiring, among other things, COVID-19 vaccinations or regular testing for millions of private sector employees.  This is part of a trilogy of vaccine mandates President Biden announced in recent weeks, and it is easily the most far-reaching: by OSHA’s estimates, the ETS will cover approximately 264,000 entities and 84.2 million employees. The requirements of the ETS include establishing and implementing a written mandatory COVID-19 vaccination policy or alternative policy requiring testing and face coverings; determining employee vaccination...

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CMS Emergency Regulations Mandate COVID-19 Vaccination of Certain Health Care Workers

On November 4, 2021, the Centers for Medicare and Medicaid Services (“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.  (See display copy.)   The Interim Final Rule will be published in the Federal Register tomorrow, November 5. Below is an initial outline of the key points of such interim final rule. Facilities covered by this regulation include the following: Ambulatory Surgical Centers Hospices Programs of All-Inclusive Care for the Elderly Hospitals Long Term Care facilities Psychiatric Residential Treatment Facilities Intermediate Care Facilities for Individuals with...

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FTC Policy Change May Signal Increased Scrutiny for “Anticompetitive” Healthcare Transactions

On October 25, 2021, the Federal Trade Commission (FTC) published a policy statement that reinstated its “prior approval” policy applicable to parties subject to an FTC order that are contemplating a future merger, acquisition or other applicable transaction.  As explained in the FTC’s press release, the “prior approval” policy was previously suspended in a 1995 FTC policy statement, which policy statement has now been rescinded.  In summary, 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 (regardless of size or the applicability of Hart-Scott-Rodino...

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Pennsylvania House Demands Transparency for Population Health Data

In an effort to further public access to Pennsylvania population health data, the Pennsylvania House of Representatives recently passed HB 1893 to amend Section 15 of the Pennsylvania Disease Prevention and Control Law. The amendment would make reports of diseases, records maintained as a result of actions taken in consequence of such reports or any other records maintained under the said law subject to the Right-to-Know Law.  This change would mean that data held by the Department of Health on all infectious diseases that are reported under the Disease Prevention and Control Law, not just COVID-19, would be accessible to the public. In the continuing wake of the COVID-19 pandemic, the...

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New Laws Expand the Autonomy of Physician Assistants in Pennsylvania

On October 7, 2021, 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. Senate Bills 397 and 398 update the scope of physician assistant practice by changing the requirement that physician assistants provide care “under the supervision and direction” of a supervising physician to require that the physician assistant need only be under the “supervision” of a supervising physician. The bills also increase the composition of the State Board of Osteopathic Medicine and the State Board of Medicine by two members, a physician assistant and a...

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The 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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