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Federal Court of Appeals Lifts Stay of Indiana’s Prohibition on Gender Transition Services to Minors

By: Stephanie T. Eckerle, Julie A. Rosenwinkel, and Brandon W. Shirley on March 19, 2024

The Seventh Circuit Court of Appeals recently issued an order permitting enforcement of Indiana’s recently passed prohibition on gender transition procedures for minors. The Indiana Legislature enacted Indiana Code § 25-1-22 (the “Act”) that was scheduled to become effective July 1, 2023. The Act…

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Indiana Unlikely to Deliver 340B a Reprieve from 340B Restrictions 

By: Brandon W. Shirley on February 13, 2024

As the conflict between 340B over the scope of the 340B drug discount program enters its fourth year, Covered Entities are increasingly turning to state law for relief from restrictions on contract pharmacies because Congress and federal agencies have been unable to make meaningful progress. The…

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Don’t Forget About the Leap Year - Annual HIPAA Breach Notification Deadline Fast-Approaching

By: Christopher J. Kulik and Stacy Walton Long on February 13, 2024

Each year, entities regulated under HIPAA must report breaches affecting less than 500 individuals to the Department of Health and Human Services (“HHS”) within sixty days following the end of each calendar year. This means that the deadline to report to HHS these type of breaches occurring in 2023…

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CMS's New Federal Prior Authorization Rule: An Eventual Step In the Right Direction

By: Meghan M. Linvill McNab and Brandon W. Shirley on February 13, 2024

CMS published a final rule, effective January 1, 2026, implementing additional processes to advance interoperability as well as to improve prior authorization processes.  The changes to prior authorization will require: (1) Medicare Advantage, Medicaid Fee-for-Service (“FFS”) and Medicaid Managed…

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Navigating Digital Privacy in Healthcare: Understanding Web Tracking and HIPAA Concerns (Podcast)

By: George C. Lepeniotis and Christopher J. Kulik on January 4, 2024


In the digital age, where information is constantly being generated, the concepts of privacy are rapidly evolving, especially in the healthcare sector. This transformation has significant implications for both healthcare providers and patients.

In this episode of the Krieg DeVault Podcast…

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The OIG’s New Unified Compliance Resource Tool: You’ve Been “Voluntold” to Comply

By: Brandon W. Shirley and Stacy Walton Long on November 29, 2023

The United States Office of Inspector General (“OIG”) published a unified compliance resource tool on November 6, 2023. While the General Compliance Program Guidance (“GCPG”) does not provide new substantive content, it does provide a single source of information relating to some of the greatest…

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Lawsuit Challenges HHS Guidance on the Use of Web Tracking Technologies

By: Stephanie T. Eckerle and Christopher J. Kulik on November 29, 2023

On November 2, 2023, parties including the American Hospital Association (“AHA”) sued the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) in a federal court in Texas. In their complaint they challenge the enforcement of an OCR guidance bulletin (the, “Bulletin”),…

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Expansion of Medicare Coverage for Behavioral Health Services

By: Meghan M. Linvill McNab and Grant M. Achenbach on November 14, 2023

As part of CMS’ annual Medicare OPPS and ASC Final Rule, it finalized new Medicare coverage of intensive outpatient program (“IOP”) services performed in hospital outpatient departments, CMHCs, FQHCs, and RHCs.  Coverage begins January 1, 2024.  This new coverage is intended to address the gap…

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President Biden Issues Executive Order on Artificial Intelligence

By: Alexandra Wilson Pantos and Shelley M. Jackson on November 2, 2023

On October 30, President Biden issued his Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, along with a companion Fact Sheet issued by the White House. The Executive Order establishes the federal government’s priorities with respect to Artificial…

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A Time to Change

By: Meghan M. Linvill McNab and Brandon W. Shirley on October 3, 2023

On August 2, 2023, CMS published the fiscal year 2024 Inpatient Psychiatric Facilities Prospective Payment System (“IPF PPS”) Final Rule. One of the included regulatory changes was to the permitted timing for a hospital to convert a rehabilitation or psychiatric unit from “non-excluded” to…

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SURPRISE! Federal Alternative Dispute Resolution Grinds to a Halt

By: Brandon W. Shirley and Meghan M. Linvill McNab on August 16, 2023

The Centers for Medicare and Medicaid Services (“CMS”) recently suspended a key procedure for resolving payment disputes between out-of-network providers and health facilities against insurers under the No Surprises Act. The procedure is the Independent Dispute Resolution (“IDR”) process. It…

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Inquiring Minds Want to Know - Limit Access to PHI to Prevent Snooping

By: Robert A. Anderson and Hillary N. Buchler on July 6, 2023

The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) recently concluded its investigation into Yakima Valley Memorial Hospital (“Yakima”). The matter illustrates the need to limit access to private health information (“PHI”) to those members of the workforce with a need…

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