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Green Practice News: April 2025

My Green Doctor

In This Issue : New Research: Teaching Patients about Climate Resilience Make the Pledge Today to Go Green Get Ready for Earth Day 2025 (part 2)! from 2000 to 2018 among people over 65 years old. Patients rely on medical professionals for guidance on how lifestyle choices impact long-term health. Contact us today! of total U.S.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. Under Medicare’s pricing formula, beneficiaries who take tafamidis are responsible for a copay of approximately $13,000 per year.

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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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 98
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DOJ Re-Brands Guidance Documents

FDA Law Blog

The federal government does its own version of rebranding with each change in administration. This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g.,

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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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 75
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The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation

FDA Law Blog

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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District Court Interprets EKRA

FDA Law Blog

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.