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Green Practice News: May 2025

My Green Doctor

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Latest news & breaking headlines And, in many countries, governments offer financial incentives to install solar panels and even backup batteries.

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FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. Greater scrutiny of RUO products and those companies that manufacture them could be one of those doors.

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CMS Proposes Rule to Implement Mandatory Medicare Part B Discarded Drug Rebates

FDA Law

An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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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

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 Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

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Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

FDA Law

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP).