As noted in our recent Health Industry Washington Watch blog post, outgoing House Speaker John Boehner and the Obama Administration have reached agreement on a two-year, $80 billion budget/debt-ceiling deal that includes Medicare and Medicaid “offsets” to finance other spending. For manufacturers of generic pharmaceuticals marketed under abbreviated new drug applications, Section 602 of the proposed … Continue Reading
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
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
On March 5, 2010, the Office of Pharmacy Affairs published a Final Notice allowing covered entities to use multiple contract pharmacies in order to supplement "in-house" pharmacy services or to increase patient access to 340B drugs. This Final Notice replaces "Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services (61 Fed. Reg. 43,549) and all other previous 340B Program guidance regarding non-network contract pharmacy services.… Continue Reading
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