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Medicaid expansion is in the eye of the beholder

The Health Policy Exchange

To the ACA's detractors, Medicaid expansion is a hostile government takeover that must be opposed in principle, regardless of potential benefits of an infusion of federal dollars. In fiscal year 2011, Medicaid spending totaled $414 billion, with two-thirds going to services for disabled elderly persons.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

2011), here , and United States v. Federal courts, too, have broadly interpreted the AKS to cover any arrangement where “one purpose” of the remuneration is to induce referrals, purchases, or orders of federally reimbursable items or services, even if the arrangement has other, legitimate purposes (see, e.g., United States v. Borrasi, 639 F.3d

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. 39,318 , 39,324 (July 6, 2011). 6 (2011) (statement of Michele M. On Commerce, Manufacturing and Trade of the H.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. 39,318 , 39,324 (July 6, 2011). 6 (2011) (statement of Michele M. On Commerce, Manufacturing and Trade of the H.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

More specific to the facts of this case than the governing statute, Jazz argues that OOPD’s determination that Lumryz is clinically superior to Xywav is inconsistent with FDA’s regulations. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

Clinic 52
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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

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