by Admin | November 18, 2016 4:06 pm
November 18, 2016—The 340B program[1] omnibus guidance, aka mega-guidance, is still penciled in for release in December 2016, according to the federal government’s latest status report on forthcoming regulatory activities.
The White House Office of Management and Budget recently released the fall edition of the Unified Agenda of Regulatory and Deregulatory Actions. The unified agenda’s timetables for action are not binding. Actual release dates for regulations and guidance documents can, and often do, differ.
The new agenda’s timetable for the 340B final mega-guidance is December 2016, the same as in the agenda’s spring edition. The Health Resources and Services Administration sent its final mega-guidance to OMB on Sept. 1[2] for review before release in the Federal Register. These reviews generally take about 90 days. Congressional Republican leaders recently asked the Obama administration to freeze new regulations during the presidential transition.
The description of the mega-guidance in the unified agenda’s fall edition differs from that in the spring 2016 edition. The new description has five new sections: Statement of Need, Summary of the Legal Basis, Alternatives, Anticipated Costs and Benefits, and Risks. Here’s what those new sections say about the mega-guidance:
Statement of Need: The Omnibus Guidance addresses key policy issues raised by various stakeholders committed to ensuring the integrity of the 340B Program and assisted covered entities and manufacturers in their ability to satisfy 340B Program requirements and expectations.
Summary of the Legal Basis: HHS is interpreting section 340B of the Public Health Service Act and issuing final guidance in critical areas.
Alternatives: None.
Anticipated Costs and Benefits: Some covered entities and manufacturers may increase spending on 340B Program compliance efforts, including assessments of patients eligible for 340B drugs. HRSA does not expect any such costs to be significant.
Risks: Not issuing the final guidance will result in a lack of clarity in some 340B areas.
The new unified agenda also continues to show the 340B civil monetary penalties for manufacturers and ceiling price regulations slated for release this month. HRSA just sent the final rule to OMB for review prior to publication on Oct. 21[3].
Like the description of the mega-guidance, the fall agenda’s description of the manufacturer CMPs and ceiling price regulation has the following additional information:
Statement of Need: The final rule provides a critical enforcement mechanism for the Department when drug manufacturers intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program. The rule also defines the standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.
Summary of the Legal Basis: Sections 340B(d)(1)(B)(vi) and 340B(d)(1)(B)(i)(I) of the Public Health Service Act.
Alternatives: None. This rule implements a statutory requirement.
Anticipated Costs and Benefits: None.
Risks: This final rule enables the Department to meet its statutory obligation under the Affordable Care Act to finalize regulations in these areas, which is expected to enhance the integrity of the 340B Program.
There is nothing in the new agenda about the 340B administrative dispute resolution process regulation. HRSA released its proposed dispute resolution regulation in August[4]; comments were due on or before Oct. 11.
Register – 340B Coalition Winter Conference – February 1-3, 2017 – San Francisco, Calif.[5]
Source URL: https://340binformed.org/2016/11/omb-reports-on-status-of-340b-guidance-and-regulations/
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