Presidential Document 15 May 2025 healthcare, regulations, pharmaceuticals, u.s. government, drug pricing

💊Executive Order on Most-Favored-Nation Drug Pricing Impact

Executive Order 14297 aims to rectify the disparity in pharmaceutical pricing between the U.S. and other developed countries. It emphasizes the need for Americans to access drugs at the most-favored-nation prices and outlines immediate policy actions to address foreign pricing disparities. The order also encourages direct-to-consumer sales at these pricing levels, asserting that U.S. patients should benefit from fair drug pricing relative to global standards.

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Notice 15 May 2025 healthcare, cms, regulation, medicare, drug pricing, inflation reduction act

💊Medicare Drug Price Negotiation Program Draft Guidance Overview

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price for 2026, 2027, and 2028 for the implementation of the Inflation Reduction Act (IRA).

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Notice 13 May 2025 regulatory compliance, information collection, centers for medicare and medicaid services, drug pricing, inflation reduction act

💊Comment Request on Drug Pricing Collection by CMS

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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Presidential Document 18 Apr 2025 healthcare, regulations, medicare, pharmaceuticals, innovation, drug pricing

💊Executive Order on Lowering Drug Prices and Its Business Implications

Executive Order 14273 seeks to restore prior initiatives aimed at lowering prescription drug prices in the U.S. The order emphasizes transparency in drug pricing, encourages competition through generics, and addresses the Medicare Drug Price Negotiation Program to enhance access to affordable medications while fostering innovation in the pharmaceutical industry.

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Notice 1 Apr 2025 regulatory compliance, healthcare, cms, information collection, medicare, drug pricing

💊CMS Medicare Drug Price Negotiation Program Information Collection Notice

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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