Health Center Regulatory Issues

HRSA Announces Inclusion of 340B Compliance Questions in Operational Site Visit

In its Primary Health Care Digest dated October 22, 2014, BPHC announced that Operational Site Visits (OSV) conducted on or after October 1, 2014 for health centers that participate in the 340B Discount Drug Pricing Program will include a “brief assessment of compliance with 340B requirements.”  According to HRSA, the OSV review team will assess 340B compliance using a set of standard questions and the responses will be reported directly to HRSA’s Office of Pharmacy Affairs (OPA) for review and follow up as needed.

On October 21, 2014, a webinar was held for the consultants who conduct the OSVs.  HRSA indicated that the task of the reviewers is to “flag” health centers that may be out of compliance with 340B, but not to actually test compliance.  OPA will provide the review team with 5 simple YES/NO questions (as indicated on the slides).  The questions include: is the health center enrolled in 340B?; If yes, do they have policies & procedures addressing the program and accounting for how the health center will prevent duplicate discounts and diversion?; Do they use contract pharmacies, and if so do they have appropriate contracts in place with clauses to prohibit duplicate discounts and diversion?  The clinical consultant is charged with the task of asking these questions and noting the responses.

If the health center participates in 340B and its policies/contracts trigger a “NO” response to any of the aforementioned questions, the team lead will share that information with OPA, which may conduct follow up.  Thus, the consultants themselves should not delve deeply into non-compliance – rather, their review may trigger a detailed review by OPA (OPA intends to conduct 200-300 audits for FY 2015).  During the call, HRSA “reminded” the consultants that determining non-compliance with or violations of the requirements was beyond the consultants’ assignment.  Nevertheless, given the extent to which some reviewers previously demonstrated difficulties under the old OSV format in distinguishing between compliance and performance improvement, it is advisable for health centers to be aware of the review parameters and notify HRSA of reviewers that appear to be acting beyond the scope of their charge.

At this time, the extent to which HRSA will update the Site Visit Guide to incorporate the five questions is unclear.  HRSA has indicated that it will issue a revised Guide shortly (presumably to incorporate new program requirements set forth in the Sliding Fee Discount Program PIN and the Budget PIN).  Insofar as the 340B requirements are not a part of the Nineteen Health Center Requirements that are assessed for programmatic compliance, it is doubtful that the 340B questions will be included in the compliance sections of the Guide.  Rather, they may be included as a separate section, similar to other non-compliance related sections currently included in the Guide.  As such, 340B findings of potential non-compliance should not result in findings of programmatic non-compliance and grant conditions.

Nevertheless, as noted above, these findings could trigger a more extensive 340B audit by OPA.  Such audits could result in any of the following sanctions, individually or in combination:

  • HRSA Sanctions
    • Prospective corrective action
    • After notice and hearing, repayment of the amount of the discount to the manufacturer, payment of interest on the discount for “knowing and intentional” diversion, and/or removal from 340B Program and disqualification for a “reasonable” period of time if the violation was “systematic and egregious
  • Collateral Sanctions
    • False Claims
    • OIG and related penalties

Accordingly, health centers should be mindful of the 340B findings by the OSV reviewers and as necessary and to the extent possible, revise their policies, procedures and contracts to incorporate 340B requirements prior a more detailed OPA review.