HRSA Plans to Issue Two 340B Proposed Rules in November

by admin | August 23, 2011 8:13 pm

August 23, 2011—The Health Resources and Services Administration (HRSA) says it will issue proposed regulations in November for the calculation of 340B ceiling prices and for fines and other penalties against 340B covered entities that knowingly divert covered outpatient drugs.

HRSA disclosed its timetable for issuing the two notices of proposed rulemaking (NPRM) in the Department of Health and Human Services’ recently issued semiannual regulatory agenda[1]. The compendium, which is required under an executive order, is a periodic forecast of the major rulemaking activities that HHS expects to undertake in the foreseeable future.

Congress directed HRSA in last year’s Affordable Care Act (ACA) to define precisely how 340B ceiling prices should be calculated and to create punishments for 340B providers that divert drugs intentionally. It did not, however, set a deadline for rulemaking on those subjects as it did for the establishment of 340B civil monetary penalties for drug manufacturers and for a 340B administrative dispute resolution process.

In the latter two cases, lawmakers gave HRSA 180 days from the enactment of health reform to promulgate rules. The agency issued advanced notices of proposed rulemaking[2] (ANPRMs) for both on Sept. 20, 2010 and accepted comments through Nov. 19[3]. But it has refrained from taking further steps in the regulatory process and said several times that it will not do so until it receives more funding[4] from Congress to carry out its expanded duties under reform.

In HHS’s new semiannual agenda, which was dated April 4 but not published until July 7, HRSA gave July 2011 as the projected timeframe for publishing NPRMs on the two subjects. In response to a request for comment on the passing of July without action, a HRSA spokesperson said “as funds have not been appropriated for these activities, we cannot estimate an actual timeline.”

“We are working as diligently as we can with the resources available to draft and publish regulations and to implement all provisions” outlined in health care reform, the spokesperson added.

In the agenda’s entry on 340B ceiling prices, HRSA said the proposed rule’s purpose will be “to implement a new statutory requirement in the Affordable Care Act to develop and publish through an appropriate policy or regulation issuance precisely defined standards and methodology for the calculation of ceiling prices for purposes of 340B.”

According to Amy VanDeCar, senior director of U.S. commercial compliance and government programs for Compliance Implementation Services, a consulting firm specializing in compliance strategies for pharmaceutical companies, in most cases “it’s pretty clear” to drug manufacturers how to calculate a drug’s 340B ceiling price. “The primary area of confusion is what to do in the exceptional situations,” she said. “It’s when the calculation is very small or very large that manufacturers are less certain about what to do.”

VanDeCar said she thinks manufacturers will welcome additional guidance from HRSA. “There is so much gray area in government pricing that clarity is always appreciated,” she said.

The lengthier unified agenda entry on provider monetary policies states that the proposed rule’s purpose is to impose new sanctions for drug diversion above those that already exist, including:

• a monetary penalty to a manufacturer or manufacturers in the form of interest on sums for which the covered entity is found liable;
• in cases where diversion is systematic and egregious as well as knowing and intentional, removing the covered entity from 340B and disqualifying it from re-entry for a reasonable period of time; and
• referring matters to the Food and Drug Administration, the HHS Office of Inspector General or other federal agencies for appropriate action under other federal statutes, such as the Prescription Drug Marketing Act.

Source URL: https://340bemployed.org/hrsa-plans-to-issue-two-340b-proposed-rules-in-november/

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