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May 23 — The latest HHS regulatory agenda pushes back the expected release dates for rules and a guidance that would affect pharmaceutical companies participating in the federal 340B drug discount program.
The agenda delays the release date for a final rule that would impose civil monetary penalties on pharmaceutical companies that charge too much for drugs in the 340B program, and a proposed rule that would establish a dispute resolution process for the program.
HHS also delayed a final guidance to address key policy issues raised by stakeholders for which the HHS doesn't have statutory rulemaking authority.
The 340B program requires drug manufacturers to provide outpatient drugs to eligible health-care organizations at significantly reduced prices.
The spring 2016 agency rule list from the Department of Health and Human Services was posted online May 18 on the Office of Management and Budget's website.
Bloomberg Intelligence analyst Brian Rye said May 23 that the Health Resources and Services Administration (HRSA), the part of the HHS that administers the 340B program, “has had difficulty implementing and enforcing 340B rules, drawing the ire of both drugmakers and hospitals.” He told Bloomberg BNA that those difficulties and these latest regulatory delays may increase the pressure on Congress to revisit the program's underlying statutes.
The final rule (RIN 0906-AA89), required under the Affordable Care Act, would impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers “who intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program and also define standards and methodology for the calculation of ceiling prices for purposes of the 340B program,” the OMB website said.
The final rule was set for publication in May. However, it will now be published in November, according to the agenda. HRSA issued the proposed civil monetary penalty rule in June 2015 (13 PLIR 876, 6/19/15).
HRSA's proposed rule (RIN 0906-AA90), also required under the Affordable Care Act, would implement “an enhancement to the 340B program by establishing a required and binding administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B program.” The OMB website noted that this administrative dispute resolution process also is available to drug manufacturers.
According to the OMB, September is the goal for publishing a proposal for the administrative dispute resolution, and it follows an advance notice of proposed rulemaking on Sept. 20, 2010 (79 Fed. Reg. 57,233). This rule also has been delayed as it was scheduled to be published in May, according to the fall 2015 regulatory agenda.
HRSA also has delayed the final so-called omnibus guidance that was scheduled to be published this fall in September. The latest agenda says it will be published in December. HRSA issued the proposed version of the omnibus guidance in August 2015 (13 PLIR 1249, 8/28/15).
Stephanie Silverman, a spokeswoman for the Alliance for Integrity and Reform of 340B (AIR 340B), an organization that includes drug companies as members, told Bloomberg BNA in a May 23 e-mail that “it is the view of AIR 340B that clear and appropriate guidance from HRSA is needed” to prioritize the interests of uninsured, vulnerable patients.
“Delays to achieving that important objective in the 340B program are unfortunate; we look forward to continuing to support HRSA in its efforts to return the program to its original intent,” Silverman said.
340B Health, a group that represents 340B hospitals, declined to comment on the delays.
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The HHS regulatory agenda is available at http://src.bna.com/fby.
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