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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Graves , 2021 U.S. EKRA Issue.

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District Court Interprets EKRA

FDA Law

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Graves , 2021 U.S. EKRA Issue.

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Debating the pros and cons of Medicare for All

The Health Policy Exchange

At current payment rates, implementation of Medicare for All could cause substantial financial difficulties for hospitals. A 2019 RAND study estimated that total national health expenditures under a Medicare for All plan would increase by only 1.8%, from $3.82 Richard Young countered that "expansion of Medicare. health care bill.

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Kerala resident doctors’ strike: a must win movement for the doctors and patients

Tiny Physician

The PG doctors strike has entered its 12th day at the time of publishing this article and it has badly affected the patient care at the Government Medical Colleges (GMCs). KMPGA put forward the following demands in front of the state government: 1. How did the Kerala Government react to these demands?

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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

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