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Medicaid expansion is in the eye of the beholder

The Health Policy Exchange

To supporters of the Affordable Care Act, legislative expansion of the Medicaid program is a welcome financial and health care bonanza for states and uninsured patients.

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Direct Primary Care - Role for the Future of Healthcare

The Direct Doctors Difference

Looking back to 2014, when we began, there were less than 100. The strength also comes from a group of physicians who want something more and something better - improved work-life balance, return of joy to practicing medicine, and a renewal of the pure physician-patient relationship where the doctor knows his or her patient well.

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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Physicians had ultimate control and exercised independent judgment over their patients healthcare decisions. Mallory , 988 F.3d 3d 730 (4th Cir. Medicare or Medicaid).

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FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., products intended for medical purposes).

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Approaches for Quelling Stigma related to COVID-19

BMJ

Many Chinese expressed their disapproval of the many untrusted sources of information online while demonstrating a high level of trust towards the central government. How to reduce the negative psychological impact MRSA isolation on patients. 2014 (28 August). National involvement is also needed to facilitate these efforts.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

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. A 2018 report by the Government Accountability Office (“GAO”) found similar issues, as well as contract pharmacy noncompliance and poor federal oversight.