Tag Archives: Prescription Drug Price Regulation

Medicaid Rebate Program Final Rule Issued….Finally!

As previously discussed here and over on Health Industry Washington Watch here, this past Thursday, CMS and OMB issued the final, 600+ page Medicaid Rebate Program Final Rule. The pre-Federal Register version of the final rule may be accessed here. While we are still processing what this will mean for drug manufacturers and other health … Continue Reading

340B Drug Pricing Program Omnibus Guidance Notice Published by Health Services Resources Administration

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA guidance, several elements will generate significant debate among program stakeholders regarding the scope of the 340B program.  In addition, the Notice presages a … Continue Reading

HRSA Publishes Proposed Rule Regarding the Exclusion of Orphan Drugs for Certain 340B Covered Entities

On May 19, 2011, the Health Resources and Services Administration (“HRSA”) released a proposed rule concerning the exclusion of orphan drugs for certain covered entities under the 340B Program. The 340B Program, enacted pursuant to the Veterans Health Care Act of 1992 (“VHCA”), limits the prices that participating manufacturers may charge for outpatient drugs purchased by … Continue Reading

Health Reform Update: Focus On Prescription Drug Price Regulation

While Congress continues to debate the "big picture" issues of broad-scale health care reform, pending bills in both the House of Representatives and Senate contain proposals to amend federal prescription drug price regulation programs such as the Medicaid rebate statute, the Public Health Service Act's Section 340B program, and Medicare Part D. For an overview of current proposals in this area and highlights of important issues for prescription drug manufacturers, distributors and dispensers, read the full alert, which also includes a chart comparing the drug pricing provisions in the key current bills.… Continue Reading