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D.C. District Court Upholds HHS's 2013 Policy of Including Part C Days in the Medicare Fraction of the DSH Calculation | King & Spalding

D.C. District Court Upholds HHS's 2013 Policy of Including Part C Days in the Medicare Fraction of the DSH Calculation | King & Spalding
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MCIT Breakthrough Devices Program Coverage Delayed

On May 14, 2021, CMS issued a new final rule that will further delay the effective date of the Medicare Coverage of Innovative Technology MCIT and Definition of Reasonable and Necessary Final Rule until no earlier than Dec. 15, 2021. ....

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New Rules May Reduce Healthcare False Claims Liability

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New Rules Prohibiting the Government s Use of Certain ‘Guidance Documents May Reduce False Claims Liability for Health Care Providers
Wednesday, February 17, 2021
Health care providers and others in the health sector have long complained at the unfairness of facing enforcement actions – and the fines and penalties that accompany them – for failure to follow a poorly publicized or otherwise obscure agency guidance such as a local coverage determination (LCD). In 2019, the United States Supreme Court provided significant relief when it held in
Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), that an agency guidance that established or changed a “substantive legal standard” had to undergo a notice-and-comment process before adoption and enforcement. On Dec. 3, 2020, the Office of General Counsel for the Department of Health and Human Services (HHS-OGC) issued an Advisory Opinion and two final rules that provide a roadmap a ....

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One Of Trump Admin.'s Top Health Attys Talks Enforcement

One Of Trump Admin. s Top Health Attys Talks Enforcement
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Law360 (February 8, 2021, 9:17 PM EST)
In an interview with Law360 after rejoining Sidley Austin LLP, one of the Trump administration s top health care attorneys discussed why False Claims Act recoveries are poised to spike, why she launched the government s new FCA working group and why Trump s enforcement legacy will prove durable under the Biden administration.
Brenna Jenny
Brenna Jenny, a partner in Washington, D.C., shared her insights during a wide-ranging interview upon her return to Sidley this month following three years in prominent posts at the U.S. Department of Justice and the U.S. Department of Health and Human Services. ....

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HHS Last-Minute Final Rule Restricts Use of Guidance Standards in Civil Enforcement Actions | Morgan Lewis

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The US Department of Health and Human Services (HHS) issued a Final Rule on January 12, 2021 on
Transparency and Fairness in Civil Administrative Enforcement Actions that amends 45 CFR Part I to set forth rules for appropriate reliance on guidance documents and requirements to give fair notice of relevant agency positions before taking a civil enforcement action that relies on any such position. The regulations purport to update HHS processes to ensure it operates with transparency and fairness so that regulated parties receive fair notice of laws and regulations to which they are subject and have an opportunity to contest an HHS determination prior to the agency taking any action with a legal consequence. ....

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