by admin | January 24, 2012 12:24 pm
January 24, 2012—The Health Resources and Services Administration (HRSA) has set May as its target[1] for issuing its long-awaited final rule to implement health care reform’s prohibition on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under reform.
The projected timeframe for publication was included in the Department of Health and Human Services’ (HHS) latest semiannual regulatory agenda, dated fall 2011 and issued on Jan. 20. The twice-a-year report gives details about the most important regulatory actions that HHS expects to take in the next six months.
[ms-protect-content id=”2799″]Target publication dates in the agenda are not written in stone and, in fact, are often missed. Other times, government agencies publish ahead of schedule. That being said, the report does provide clues about which HRSA regulations and guidance documents are in motion and which are on the back burner.
“Active Actions”
For example, the orphan drug exclusion rule is the only 340B-related HRSA entry in the agenda categorized as an “active action.” There have been conflicting reports, however, about just how “active” the orphan drug rule is. Some 340B insiders say the final rule could be out as soon as this February. Others say that, in an election year, political appointees at HHS will be reluctant to move any rule that smacks of controversy.
The orphan drug exclusion rule has indeed been controversial. Provider groups praised HRSA’s proposed rule last May[2], which would let rural and freestanding cancer hospitals new to 340B buy orphan drugs at 340B-discounted prices when they use the medicines to treat non-orphan diseases or conditions. Drug manufacturers have argued that the Affordable Care Act’s (ACA) limit on 340B pricing for new covered entity types should apply to all pharmaceuticals with an orphan designation that are approved to be marketed in the United States and without regard to how they are used. HRSA’s proposed rule, some manufacturers say, would gut the exclusion, which was added without debate to a budget bill passed in tandem with the reform law[3] during the last step before ACA’s final passage.
“Long-Term Actions”
The regulatory agenda lists two other 340B rules that HRSA must issue under ACA—civil monetary penalties (CMPs) for manufacturers and mandatory dispute resolution—as “long-term actions.” HRSA also listed two other rules—for standards and methods for the calculation of 340B ceiling prices and for the establishment of CMPs for covered entities—as long-term projects. ACA did not require HRSA to implement these two provisions by regulation.
The ceiling price and covered entity CMP proposed actions made their first public appearance[4] in the spring 2011 regulatory agenda, which came out last July. At the time, HRSA said it anticipated publishing notices of proposed rulemaking for both in November. Now, it says the timing of the proposed rules is “to be determined.”
HRSA issued advanced notices of proposed rulemaking[5] for manufacturer CMPs and mandatory dispute resolution on Sept. 20, 2010 and accepted comments through Nov. 19[6] of that year. As with the other long-term actions, it says the timing of notices of proposed rulemaking for these two is “to be determined.”
Missing from the regulatory agenda is perhaps the most anxiously awaited pending interpretation of 340B of all—HRSA’s definition of “patient” for purposes of 340B drug discounts.
HRSA sent a new proposed definition to the Office of Management and Budget (OMB) for review on Jan. 21, 2011 and the office returned it with unspecified changes[7] on April 20. During a July 2011 meeting of 340B stakeholders[8], Office of Pharmacy Affairs Director Krista Pedley said it was back under review and could remain so for quite some time. Two months later in its landmark report on 340B, the Government Accountability Office[9] (GAO) called on HRSA to finalize a new, more specific definition.[/ms-protect-content]
Source URL: https://340bemployed.org/will-340b-orphan-drug-final-rule-come-out-in-may/
Copyright ©2025 340bemployed.org unless otherwise noted.