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Health Law News

Is Five the Magic Number for OPDP Enforcement Letters in 2023?

[12/15/23]

Posted on December 15, 2023 in Health Law News

Published by: Hall Render

After a slow start to the year, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) now has a total of five enforcement letters for 2023 (four Untitled Letters and one Warning Letter) with potentially the last two letters of 2023 issued on Halloween. Our summary of the first three letters... READ MORE

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Weekly Health Care Real Estate Briefing: Nonprofit Health Systems Experience Losses, While For-Profits Stabilize | Medical Office Sector Shows Signs of Weakening

[12/08/23]

Posted on December 8, 2023 in Health Law News

Published by: Hall Render

Hospitalogy published a roundup of recent earnings reports for a number of health systems. Several large, nonprofit health systems experienced losses in the recently ended quarter, while CVS Health and other for-profit providers reported profits and earnings growth. A recent Bisnow article indicated that, despite showing more resilience than the general office sector, the... READ MORE

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Health Provider News

[12/08/23]

Posted on December 8, 2023 in Health Law News, Health Provider News

Published by: Hall Render

NATIONAL 8.5M Records Impacted By Welltok Data Breach Stemming From MOVEit Hack 60% of employed physicians required to sign noncompetes 6.9 Million 23andMe Users Affected by Data Breach American Hospital Association debuts national patient safety initiative AHA voices ‘deep concern’ in restricting provider-based Medicaid funds AHA-supported bill would prohibit HHS from finalizing long-term care... READ MORE

Sixth Circuit Weighs in on Accommodating a Nursing Student’s Service Animal

[12/07/23]

Posted on December 7, 2023 in Health Law News, HR Insights for Health Care

Published by: Hall Render

The Sixth Circuit Court of Appeals (“the Court”) recently affirmed the dismissal of a nursing student intern’s lawsuit alleging disability discrimination and failure to accommodate claims. The Court opined that the plaintiff in this action failed to establish an intentional discrimination claim against Hurley Medical Center (“Hurley”) and that Hurley did not fail to... READ MORE

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CMS Finalizes Major Changes to Hospital Price Transparency Rule

[12/04/23]

Posted on December 4, 2023 in Health Law News

Published by: Hall Render

The Centers for Medicare & Medicaid Services (“CMS”) finalized significant updates to the Hospital Price Transparency regulation for the first time since the rule took effect on January 1, 2021. Many of the changes included in the CY 2024 Medicare OPPS and ASC Final Rule will affect all hospitals and necessitate updates, modifications and in... READ MORE

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Weekly Health Care Real Estate Briefing: Mayo Clinic Plans $5B Expansion in Minnesota | Healthpartners Moving Forward with $400M Hospital I Optum Is the Largest Employer of Physicians

[12/01/23]

Posted on December 1, 2023 in Health Law News

Published by: Hall Render

Mayo Clinic unveiled a $5B plan to redesign its Rochester, Minnesota campus. The plan includes creating “health neighborhoods” within the campus that will focus on certain patient needs. CommonSpirit Health has closed on a $5M impact investment to support an affordable housing community in San Francisco called Freedom West Homes. Becker’s published a summary... READ MORE

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Health Provider News

[12/01/23]

Posted on December 1, 2023 in Health Law News, Health Provider News

Published by: Hall Render

NATIONAL 340B drug discount program yields mixed evidence on how hospitals use funds 3 in 5 Patients Accessed Health Records Online or Via Apps in 2022 Acute hospital care at home gets good grades from CMS research AHA-supported bill would ban health plan fees for electronic fund transfers AHA-supported bill would extend Medicare programs... READ MORE

A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

[11/30/23]

Posted on November 30, 2023 in Health Law News

Published by: Hall Render

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Traditionally, the FDA exercised enforcement discretion over LDTs, meaning that the FDA has... READ MORE

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2024 Medicare Physician Fee Schedule Final Rule Makes Changes to Medicare Shared Savings Program

[11/29/23]

Posted on November 29, 2023 in Health Law News

Published by: Hall Render

On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued the 2024 Medicare Physician Fee Schedule Final Rule (“Final Rule”) for calendar year (“CY”) 2024. Among other changes, the Final Rule refines and builds on changes finalized in the CY 2023 Physician Fee Schedule Final Rule to the Medicare Shared Savings... READ MORE

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Home Health PPS Final Rule for CY 2024: CMS Steps Back from the Brink

[11/28/23]

Posted on November 28, 2023 in Health Law News

Published by: Hall Render

On November 1, 2023, the Centers for Medicare & Medicaid Services (“CMS”) posted a pre-publication copy of the Calendar Year (“CY”) 2024 Home Health Prospective Payment System Rate Update Final Rule (“2024 Final Rule”), which has since been filed in the Federal Register. The 2024 Final Rule was the subject of a significant amount... READ MORE

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