340B Manufacturer Civil Monetary Penalty Proposed Regulation Slated for July

by admin | May 22, 2015 11:41 am

May 22, 2015— A 340B program proposed regulation establishing civil monetary penalties for drugmakers that intentionally overcharge and setting standards for calculating 340B ceiling prices is penciled in for July, according to the latest edition of the federal government’s regulatory agenda.

Another proposed regulation creating a mandatory and binding 340B administrative dispute resolution process is slated for December. Proposed omnibus 340B program guidance remains on schedule.[ms-protect-content id=”2799″]

The Department of Health and Human Services published the updated timelines for releasing the proposed regulations and guidelines yesterday[1] in the spring 2015 edition of the federal government’s unified regulatory agenda. The release dates given in the agenda are projections, not hard deadlines.

HHS’s Health Resources and Services Administration sent its proposed 340B rule on manufacturer civil monetary penalties and ceiling price calculation to the White House Office of Management and Budget on April 8[2]. Ninety days out from then is early-to-mid July, which squares with new unified agenda’s timeline.

HRSA has not yet sent its proposed dispute resolution rule to OMB. If one works backward from the agenda’s projection that it will be published in the Federal Register in December 2015, it would appear HRSA is on track to send the dispute resolution rule to OMB for review sometime in September.

HRSA on May 6[3] sent its proposed 340B guidelines to OMB for review prior to publication in the Federal Register. If the review lasts the average length of time (about 90 days) and ends with OMB granting its approval, the guidance might come out in early August. The new unified regulatory agenda shows the timeframe as September, which presumably gives HRSA some wiggle room.

HRSA Office of Pharmacy Affairs Director Cmdr. Krista Pedley previously has said the omnibus guidance would cover patient definition, hospital eligibility, contract pharmacy, annual covered entity recertification, audits, Medicaid fee-for-service and managed care duplicate discounts, manufacturer limited distribution plans, manufacturer refunds and credits to covered entities, “and more.”

Hospital groups cited the forthcoming guidance this past week in urging the House Energy & Commerce Committee not to add 340B provisions to the 21^st Century Cures Act. Congress, they said, should not consider legislative changes to 340B at least until the guidance is published. The committee passed the Cures bill yesterday[4] without 340B language. Last weekend, Energy & Commerce Committee staff circulated draft 340B legislation for potential inclusion in the Cures bill that addressed many of the issues HRSA is expected to address in its guidance.[/ms-protect-content]

Endnotes:

yesterday: http://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=0900&Image58.x=58&Image58.y=7&Image58=Submit
on April 8: http://340binformed.associationbreeze.com/2015/04/340b-rule-on-civil-fines-for-drugmakers-moves-closer-to-release/
on May 6: http://340binformed.associationbreeze.com/2015/05/hrsa-sends-340b-omnibus-guidance-to-omb/
yesterday: http://340binformed.associationbreeze.com/2015/05/house-panel-passes-cures-initiative-minus-340b-language/

Source URL: https://340bemployed.org/340b-manufacturer-civil-monetary-penalty-proposed-regulation-slated-for-july/