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New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

Health Law RX

On October 4, 2023, Deputy Attorney General Lisa Monaco announced a new Department of Justice (DOJ) safe harbor policy (the DOJ Announcement ), which incentivizes voluntary self-disclosures by acquiring companies during or immediately after mergers and acquisitions (the M&A Safe Harbor). The M&A Safe Harbor protects the buyer.

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Nursing Home Update: CMS Updates and Expands Surveyor Guidance for Nursing Homes for Phase 2 and 3 Requirements of Participation – Key Areas and Timeline

Hall Render

The Centers for Medicare & Medicaid Services (“CMS”) has given surveyors new rules and updates to allow surveyors to add extra attention and increase oversight in nursing homes regarding the quality of care and quality of life for residents. Phase 3 Elements. Background. Areas with Significant Updates. Compliance and ethics.

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Design, Empathy and Ethics Come to Healthcare: HXD

Health Populi

I’m blogging live while attending HXD 2018 in Cambridge, MA, the health/care design conference convened by Mad*Pow, 26th and 27th June 2018. We have a “responsibility to imagine unintended consequences,” Sara believes, and in 2018 we are not at a loss for examples — like autonomous cars as a risk factor for accidents and possibly mortality.

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The Cobra Effect & Enforcing Compliance Standards

AIHC

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. One of the seven items, #5 is “Enforcing Standards: Consequences and Incentives.”

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The Cobra Effect & Enforcing Compliance Standards

AIHC

Lessons Learned about Consequences & Incentives Submitted by the AIHC Education Department Introduction The Office of Inspector General has released the new General Compliance Program Guidance or “GCPG” in late 2023. One of the seven items, #5 is “Enforcing Standards: Consequences and Incentives.”

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CMS Issues CY2024 Proposed Rule for Medicare Advantage Organizations and Part D Sponsors

Healthcare Law Blog

The Proposed Rule includes changes on an array of topics including: Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, behavioral health services, identification of overpayments , requirements for valid contract applications, and formulary changes.

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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. So far, the would-be liability expanders haven’t done very well. 1145, 1165 n.135