Delaware Primary Care Update

On October 1, 2021, Delaware Governor John Carney signed into law Senate Bill 120, groundbreaking legislation designed to address how Delaware healthcare is delivered and paid for, with particular emphasis on primary care.  The bill’s sponsor, state senator Bryan Townsend, described its primary theme: It simply makes it clear the priority in Delaware is to keep people healthy in a healthcare system, and the way to do that is to invest more in primary care. Keep people healthy on the front‑end, rather than just waiting for people to be unhealthy on the back‑end.[i] The law requires: The Delaware Healthcare Commission to monitor compliance with both value‑based care delivery and alternative...

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

The Federal Trade Commission and the U.S. Department of Justice issued a “Request for Information on Merger Enforcement” on January 18, 2022 (the “Request”) asking for input from all sources and interested parties regarding a myriad of issues as the government plans on drafting updated “merger” guidelines. The Request specifically is seeking input with respect to both the 2010 Horizontal Guidelines and the 2020 Vertical Guidelines (which were withdrawn) issued by the agencies. The public comment period is 60 days. The agencies have stated that they believe that recent enforcement has been too permissive, especially in the area of digital markets, and specifically asks for comment as to...

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LLCs Remain a Strategic Option for Tax-Exempt Healthcare

A recent IRS notice has reinvigorated the discussion around utilizing limited liability companies (LLCs) in connection with Section 501(c)(3) tax-exempt organizations, including charitable health systems and related healthcare organizations.  More specifically, last October, the IRS released Notice 2021-56, which provided more definitive guidance on LLCs obtaining their own Section 501(c)(3) tax-exemption, which, although not a new concept, could be a useful tool for tax-exempt healthcare. Under the IRS “check-the-box” regulations, LLCs have flexibility to elect their federal tax status.  By default, an LLC owned by a single organization is a disregarded entity for federal income tax...

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It’s 2022—Are You Ready for Group Practice Changes?

January 1 comes with significant changes for physician practices that operate as group practices under the Stark Law. Though the “split pooling” profit sharing model will be eliminated, group practices gain notable opportunities in distributing Designated Health Services (DHS) profits and productivity bonuses based on the broadly defined regulatory concept of “value-based enterprise.” Back in December 2020, practically a lifetime ago, we posted a summary of the Centers for Medicare & Medicaid Services (CMS) final regulations that were published December 2, 2020. You can read that summary here. Those final regulations made substantial changes to the Stark Law, many of which went into...

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Infrastructure Deal Includes Grants for Nonprofits to Make Energy-Efficient Upgrades

President Biden signed the $1.2 trillion Infrastructure Investment and Jobs Act (the “Act”) into law on November 15, 2021. Included in the Act is a pilot program for making federal grants to tax exempt 501(c)(3) organizations to upgrade buildings owned and operated by such organizations in order to achieve more energy efficiency. The Act specifically contemplates the installation of materials on buildings that reduce the building’s use of fuel and other energy, such as upgrades to roofing material, lighting systems, windows, doors, and HVAC systems (including insulation, wiring, and plumbing improvements needed to service a more efficient HVAC system). Individual grants are capped at...

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

On December 14, 2021, the Office of Inspector General (OIG) posted an update to the Corporate Integrity Agreements FAQ on whether an entity that is subject to a Corporate Integrity Agreement (CIA) should disclose a Reportable Event, as defined below, through the CIA or through the OIG’s Self-Disclosure Protocol. A CIA is a document that outlines the obligations to which an entity agrees as part of a civil settlement. An entity agrees to the CIA obligations in exchange for the OIG’s agreement that it will not seek to exclude the entity from participation in Medicare, Medicaid or other federal health care programs. CIAs require that the provider report all Reportable Events, generally within...

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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.[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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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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