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Sixth Circuit: Technical Physician Signature Deficiencies not "Material" to Reimbursement Claims
  • Jones Day
  • USA
  • August 9 2017

The United States District Court for the Middle District of Tennessee held that the timing requirements under 42 C.F.R. 424.22(a)(2) for a


Yates Memo's Influence Felt in DOJ Health Care Enforcement
  • Jones Day
  • USA
  • August 1 2017

Almost two years after Sally Yates, then Deputy Attorney General, issued a memorandum regarding individual accountability for corporat


Telehealth & EHR Meaningful Use PaymentsExpect Greater Scrutiny in Upcoming Medicare Audits
  • Jones Day
  • USA
  • July 25 2017

In July 2017, the United States Department of Health and Human Services' Office of Inspector General ("OIG") revealed two new Work Plan items related


Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art
  • Jones Day
  • USA
  • July 7 2017

In a final written decision in Bass, et al., v. Fresenius Kabi USA, LLC (IPR2016-00254), the PTAB found that the challenged claims of Fresenius's U.S


Court Overreaches in Requiring Medical Necessity Determination by Labs
  • Jones Day
  • USA
  • June 30 2017

A district court in Washington, D.C. has held that alleging a laboratory's failure to independently verify the medical necessity of tests ordered by


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 5
  • Jones Day
  • European Union, USA
  • June 30 2017

On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing


False Claims Act: Circuit Court Questionably Construes Scienter Requirement
  • Jones Day
  • USA
  • June 21 2017

The U.S. Court of Appeals for the Eleventh Circuit recently issued an opinion addressing the False Claims Act's intent requirement. U.S. ex rel. Phalp


Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval
  • Jones Day
  • USA
  • June 21 2017

Intended to provide a faster route to approval for generic biologics, the Biologics Price Competition and Innovation Act, was the basis for a


Telemedicine in the Emergency Department and EMTALA Compliance
  • Jones Day
  • USA
  • June 16 2017

Although enacted more than 30 years ago, the Emergency Medical Treatment and Labor Act ("EMTALA") remains aggressively enforced and important for


"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement
  • Jones Day
  • USA
  • June 16 2017

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for