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Massachusetts to Require Licensure for Non-Resident Pharmacies in 2025

By: Stephanie T. Eckerle and Madison Hartman Harada on February 10, 2025

The Massachusetts Board of Registration in Pharmacy (the “Board”) announced, via updated Non-Resident Licensure FAQs on November 19, 2024,  that it will now require non-resident pharmacies to be licensed in order to dispense prescription products into the state. Massachusetts has historically…

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Approaching Deadline to Submit HIPAA Breach Notifications to HHS

By: Stacy Walton Long and Christopher J. Kulik on February 4, 2025

Under the HIPAA Breach Notification Rule, 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. Therefore, the deadline to report 2024 breaches…

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HIPAA Wrapped: OCR’s 2024 HIPAA Highlights

By: Stacy Walton Long and Thomas M. Abrams on February 3, 2025

OCR Director Melanie Fontes Rainer released an announcement on January 7, 2025 recapping OCR’s HIPAA accomplishments and enforcements in 2024. (“Announcement”).  In the Announcement, Rainer highlights new rules implemented and enforcement actions taken by her agency in 2024. Covered entities should…

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CMS Reporting Requirements for Nursing Facilities: Fast Tracking the Start Line

By: Meghan M. Linvill McNab and Andrew N. Warner on October 22, 2024

As we previously reported, 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.  Most notable and complicated of these new requirements…

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Is the Heyday of Whistleblowers Coming to a Close?

By: Alexandra Wilson Pantos, Marc T. Quigley, Thomas J. Costakis, and Libby Yin Goodknight on October 7, 2024

Under the False Claims Act (“FCA”), whistleblowers (known as qui tam relators) are able to initiate and direct the litigation of cases that seek recovery for alleged injuries to the federal government. 31 U.S.C. § 3730(b). The penalties for FCA violations are astronomical – with penalties up to…

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Physician Non-Competes in Indiana – The Old, the New, and the Future

By: Stephanie T. Eckerle, Scott S. Morrisson, and Grant M. Achenbach on July 25, 2024

Restrictive covenants in Indiana have long been a topic of litigation and debate for health care providers, private practices, and health systems.  Historically, and before there were statutory restrictions for physician non-competes, there is a long line of cases that have required physician…

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HHS Finalizes Enforcement Stick For Health Care Providers Committing Information Blocking

By: Stacy Walton Long and Christopher J. Kulik on July 23, 2024

Effective July 31, 2024, health care providers will be subject to “disincentives” for committing information blocking. As codified under the 21st Century Cures Act, information blocking is when an “actor” (e.g. health care provider) interferes with the access, exchange, or use of electronic health…

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Party Like It's July 1, 2024

By: Grant M. Achenbach and Brandon W. Shirley on June 5, 2024

The beginning of July always brings fireworks, cookouts, patriotic festivities, and a laundry list of new laws with a July 1 effective date. This year is no different, as several new laws applicable to health care providers were enacted by the Indiana General Assembly during the 2024 legislative…

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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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