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Brownstein Hyatt Farber Schreck LLP | USA | 21 Jun 2019

Medicare Rulemaking After Azar v. Allina Health Services

The Medicare Program, established in 1965, initially seemed simple: provide health care for senior citizens by paying hospitals and doctors directly


Morgan Lewis | USA | 20 Jun 2019

FDA Clarifies Premarket Path for Ecigarette Products

The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic


FisherBroyles LLP | USA | 18 Jun 2019

Chiedi Takes Over as HHS Inspector General - Promises Aggressive Enforcement

On June 1, Joanne Chiedi assumed the role of Acting Inspector General at the U.S. Department of Health and Human Services following the departure of


Loeb & Loeb LLP | USA | 16 Jun 2019

Former Shire Subsidiary Executive Reaches $2.5M Settlement

Kevin Rakin, former president of a Shire PLC subsidiary, has reached a settlement with the Department of Justice, resolving False Claims Act


McGuireWoods Consulting LLC | USA | 10 Jun 2019

Supreme Court Rules HHS Cannot Take Short-Cuts in Rulemaking

In a 7-to-1 decision, the U.S. Supreme Court on June 3, 2019, held that “Because the Department of Health and Human Services neglected its statutory


Loeb & Loeb LLP | USA | 6 Jun 2019

FDA Regulatory and Compliance Monthly Recap May 2019

According to the letter, the diagnostics company made changes impacting the performance of its potassium assay without notifying the FDA. Since the


Cozen O'Connor | USA | 6 Jun 2019

HHS Publishes Conscientious Objector Rule for Health Care Entities: Litigation Follows

On May 22, 2019, the federal Department of Health and Human Services (HHS) published a final rule that is intended to protect “individuals and health


Dinsmore & Shohl LLP | USA | 4 Jun 2019

HHS Publishes New Fact Sheet on Business Associate Direct Liability

On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new Fact Sheet providing a compilation


Dinsmore & Shohl LLP | USA | 4 Jun 2019

HHS Proposes New Rule to Revise Section 1557 and Repeal Notice Requirements

On May 24, 2019, the U.S. Department of Health and Human Services (HHS) proposed revisions to regulations issued under Section 1557 of the Affordable


Riker Danzig Scherer Hyland & Perretti LLP | USA | 4 Jun 2019

Supreme Court Rejects Health and Human Services' 2014 DSH Reimbursement Formula

With $4 billion in payments to disproportionate share hospitals (“DSH”) at stake, SCOTUS rejects Health and Human Services’ 2014 Medicare DSH

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