December 3, 2014—The Health Resources and Services Administration plans to publish two 340B program regulations next year, one in April and the other in September, according to the federal government’s latest agenda of upcoming regulatory actions.[ms-protect-content id=”2799″]
The first rule would set standards for calculating 340B ceiling prices and establish civil monetary penalties for drug manufacturers who intentionally overcharge. The second would create a mandatory and binding 340B administrative dispute resolution process. Their anticipated release dates are subject to change.
In striking down HRSA’s 340B orphan drug exclusion regulation last May, a federal district judge found that Congress specifically authorized 340B rulemaking on ceiling prices, manufacturer sanctions, and dispute resolution. In response to the decision, HRSA last month withdrew its long-awaited comprehensive 340B program regulation. It said it would instead address key 340B policy issues in “a proposed guidance for notice and comment” in 2015. The “best path forward” following the orphan drug ruling, it said, “is to issue proposed rules where the statute is specific about rulemaking” and to “issue guidance where interpretation of the statutory requirements is needed to inform the implementation of the program.”
According to the new government-wide agenda of forthcoming regulations, in addition to the so-called 340B mega-reg, HRSA also has withdrawn three other previously announced proposed regulations. These would have:
- established civil monetary penalties for 340B covered entities,
- established the extent to which state AIDS Drug Assistance Programs can collect 340B rebates from drug manufacturers, and
- modified the allowable uses of 340B program income for National Hemophilia Treatment Program grantees.
The Centers for Medicare & Medicaid Services, meanwhile, has again postponed its Medicaid covered outpatient drug final rule, commonly called the AMP rule. The new target is April.
Also, in March, CMS is scheduled to issue a proposed rule to “align Medicaid Managed Care regulations with existing commercial, Marketplace, and Medicare Advantage regulations.”[/ms-protect-content]