💊Overview of 340B Drug Pricing Program Compliance Requirements
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More💊340B Program Notice
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all covered entities, and to collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in this Notice. OPA will consider comments received but is under no obligation to respond to or act on the comments. This Notice is effective immediately as published, unless revised by a future notice. OPA reserves the right to issue revisions or addenda to this Notice at a later date (including, but not limited to, revisions or addenda informed by public comment).
Learn More💊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.
Learn More💊Medicare Drug Price Negotiation Program Draft Guidance Overview
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price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).
Learn More💊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.
Learn More💊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.
Learn More💊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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