On Monday, April 18th, the Health Resources and Services Administration (“HRSA”) and the Department of Health and Human Services (“HHS”) reopened the comment period for their proposed rule “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” (“Proposed Rule”).  Originally issued on June 17, 2015, the Proposed Rule sought to implement the civil monetary penalty (“CMP”) and ceiling price calculation provisions created by the 2010 amendment to Sec. 340B of the Public Health Service Act (“PHSA”) (for additional information on the Proposed Rule, please see our October 2015 webinar materials on the subject).  Comments were due August 17, 2015 and stakeholders vigorously commented on HRSA’s proposed penny policy for the ceiling price calculation, the lack of clarity regarding the new drug estimate calculation, and the liability standard for CMPs.

Subsequent to the Proposed Rule, HRSA issued its draft Omnibus Guidance on August 28, 2015.  The Omnibus Guidance, in addition to proposing a new “patient” definition, also provided additional examples that could lead to manufacturer CMP liability, including the requirement that manufacturers issue refunds and credits to 340B covered entities (for additional information on the Omnibus Guidance, please see our October 2015 webinar materials on the subject).  Many stakeholders noted the piecemeal nature of HRSA’s regulatory activity and called for the reopening of the comment period for the Proposed Rule, particularly since the Omnibus Guidance further elaborated on situations that may lead to CMP liability.

It seems HRSA may have listened to the many concerns raised. In its notice of the reopening of the comment period, HRSA stated it is specifically seeking comment on alternatives to the penny pricing proposal as a limited ceiling price.  HRSA noted that commenters suggested a number of alternatives to penny pricing, including use of the “federal ceiling price, the most recent positive ceiling price from previous quarters, nominal sales price.”  HRSA is “considering whether any of these alternatives or other alternatives not raised by the commenters, alone or in combination, would be more appropriate than the penny pricing policy.”  HRSA is therefore seeking comment on whether HRSA should adopt an alternative policy to penny pricing.

HRSA is also seeking comment on the specific methodology for estimating new covered outpatient drug pricing.  The proposed methodology lacked clarity regarding the standard two-quarter lag for calculation of new drug prices and required manufacturers to recalculate and issue refunds to covered entities at the start of the fourth quarter – a difficult, if not impossible, task.  HRSA noted that they received several alternative methodologies, including setting the price of new covered outpatient drugs as WAC minus the applicable rebate percentage (e.g. 23.1% for most single-source and innovator drugs, 13% for generics and OTCs).  HRSA is seeking comment on the new drug estimate calculation, as well as comments on the proposed quarter in which manufacturers will be required to issue refunds post-recalculation.

Finally, HRSA is seeking comment on the definition of “knowing and intentional” as a standard for manufacturer CMP liability.  Under section 340B(d)(1)(B)(vi) of the PHSA, the Secretary is charged with issuing CMPs for manufacturers who have “knowingly and intentionally” charged a covered entity a price that exceeds the 340B ceiling price.  The Proposed Rule did not define “knowing and intentional,” leading to a number of questions as to the precise point at which CMP liability is imposed.  HRSA is seeking comment on whether “knowing and intentional” should be further defined and provided possible definitions of “(1) [a]ctual knowledge by the manufacturer, its employees, or its agents of the instance of overcharge; (2) willful or purposeful acts by, or on behalf of, the manufacturer that lead to the instance of overcharge; (3) acting consciously and with awareness of the acts leading to the instance of overcharge; and/or (4) acting with a conscious desire or purpose to cause an overcharge or acting in a way practically certain to result in an overcharge.”  Further, HRSA is seeking comment on the circumstances in which the requisite intent “should and should not be inferred.”  HRSA specifically solicited comment on situations in which manufacturers would not be considered to have the requisite intent, such as:

  • The manufacturer made an inadvertent, unintentional, or unrecognized error in calculating the ceiling price;
  • A manufacturer acted on a reasonable interpretation of agency guidance; or
  • When a manufacturer has established alternative allocation procedures where there is an inadequate supply of product to meet market demand, as long as covered entities are able to purchase on the same terms as all other similarly-situated providers.

Comments are due on or before May 18, 2016. We expect to see a great deal of interest on alternatives to the penny pricing policy and the intent element of the “knowing and intentional” standard.   Interested stakeholders should consider taking this opportunity to express their views to HRSA, particularly in light of the new circumstances created by the interplay of the Proposed Rule and the draft Omnibus Guidance.  Considering the rapid growth of the 340B program in the past 10 years, the stakes are high for all interested parties.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
  • the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.