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HIPAA Sanction Policies: The Importance of Enforcement

By: Stephanie T. Eckerle and Shelley M. Jackson on June 3, 2024

Covered Entities as defined in the Health Insurance Portability and Accountability Act and its implementing regulations (“HIPAA”), including health care providers and health plans, must have HIPAA policies and procedures in place to protect the privacy and security of patients’ protected health…

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The Final Direction: New Final Medicaid Rules for State Directed Payments

By: Meghan M. Linvill McNab and Grant M. Achenbach on May 20, 2024

Just over a year after the rule was first proposed, and after receiving over 400 comments, the Centers for Medicare and Medicaid Services (“CMS”) finalized its managed care access, finance, and quality rule (“Final Rule”). While the rule covers a wide range of managed care topics in its 895 pages,1…

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Changes to HIPAA Privacy Rule to Support Reproductive Health

By: Christopher J. Kulik on May 20, 2024

On April 26, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (“HHS-OCR”) published a final rule (the “Rule”), which amends the HIPAA Privacy Rule to afford greater reproductive health care privacy protection.  Highlights of the new Rule that will have a practical…

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New Additions to Federal Anti-Discrimination Rules Giving Healthcare Providers Regulatory Déjà Vu

By: Brandon W. Shirley on May 20, 2024

On May 6, 2024, the Department of Health and Human Services (HHS) adopted a final rule that extends existing anti-discrimination rules for healthcare providers participating in federal healthcare programs. The new rule specifically adds protections for LGBTQI+ individuals, including those based on…

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FTC Issues Rule Banning Non-Compete Agreements

By: Scott S. Morrisson, Elizabeth M. Roberson, and Chloe N. Craft on April 25, 2024

On April 23, 2024, the Federal Trade Commission (FTC) announced its final rule banning virtually all employee non-compete agreements nationwide in approximately 120 days. The FTC initially issued its proposed rule in January 2023. The FTC thereafter received and considered over 26,000 comments to…

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Indiana Enacts Senate Enrolled Act 9 Requiring Notice of Certain Health Care Transactions

By: Brian M. Heaton and Maria Vladimirova Geltz on April 23, 2024

On March 13, 2024, Governor Eric Holcomb signed Senate Enrolled Act 9 (“SEA 9”) into law, requiring advance reporting for certain mergers and acquisitions involving Indiana health care entities. Indiana joins a number of other states with similar reporting requirements, although the drafting of SEA…

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False Claims Act Jury Verdict Halved as Unconstitutionally Excessive

By: Marc T. Quigley and Matthew C. Branic on March 26, 2024

How much is too much when it comes to damages awards for False Claims Act violations? A district court judge in Minnesota weighed in recently in United States of America ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc. et al., No. 13-cv-3003 (D. Minn.), holding that the jury’s $487 million verdict…

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Updated CMS Reporting Requirements for Nursing Facilities

By: Meghan M. Linvill McNab and Andrew N. Warner on March 26, 2024

On November 17, 2023, the Centers for Medicare & Medicaid Services ("CMS") issued a Final Rule implementing certain requirements in the Affordable Care Act regarding the disclosure of ownership, managerial and other information for Medicare and Medicaid participating nursing facilities. The Final…

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New HHS Guidance: Safeguarding Patient Rights in Hospital and Long-Term Health Facility Visitation Policies

By: Stephanie T. Eckerle, Christopher J. Kulik, and Chloe N. Craft on March 19, 2024

On January 25, 2024, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) issued new guidance to U.S. hospitals and long-term care facilities regarding their duties under the Centers for Medicare and Medicaid Services (“CMS”) regulations. Specifically, OCR…

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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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