Health Center Regulatory Issues

HRSA Issues New Governance Policy & Revised Health Center Program Site Visit Guide Impacting Health Center Governance and Operations

As we mentioned earlier, the Health Resources and Services Administration  (HRSA) recently issued two new documents, the long-awaited final governance PIN and the revised site visit guide.  Both are incredibly important to health centers, and we have prepared a detailed analysis for your benefit below.  We also encourage you to take a closer look at these documents as well, to ensure you fully understand the new requirements.

New Governance PIN #2014-01

On January 27, 2014, HRSA issued the long-awaited final governance policy – Policy Information Notice (PIN) #2014-01: Health Center Program Governance – which applies to all health center grantees, look-alike entities, and sub-recipients.  As many of you may remember, HRSA issued a draft version of this policy in the latter half of 2009.  The final PIN is very similar to the draft version, with a few minor revisions.  The new PIN clarifies existing statutory and regulatory governance requirements, incorporating existing policy interpretations previously published in several different guidance documents.  It is important to note that other than the prior governance PIN #98-12, PIN #2014-01 does not supersede those other guidance documents unless provisions of those documents conflict with the requirements set forth in PIN #2014-01.  Thus, the new PIN serves as the primary but not sole HRSA policy source for information regarding health center governance requirements.

Specific clarifications of and modifications to existing policy include the following:

  • Clarification of the definition of “patient” for board representation purposes
    • A patient board member must be an individual who is a current registered patient of the health center who has accessed the health center in the past 24 months and has received at least one in-scope service that generated a health center visit
    • An individual who is a legal guardian of a patient who is a dependent child or adult or an individual who is a legal sponsor of an immigrant may serve as a “patient” board member on behalf of such dependent or immigrant.
  • Clarification that non-patient board members do not have to reflect specific expertise in all areas listed in the health center regulations and the PIN.
  • Clarification of the governance waivers available to health centers serving sparsely-populated areas and special population-only health centers (previously published in PIN #98-12).  The PIN eliminates the ability to waive the monthly meeting requirement.  While eligible centers can still request a waiver of the 51% patient majority requirement, HRSA will apply stricter scrutiny in obtaining and maintaining composition waivers.
  • Clarification of the public entity – co-applicant board relationship, and each entity’s roles and responsibilities (previously published in PIN #99-09), including clear statements that: (1) the public entity may not override or overrule the final approvals and required decision-making authorities of the co-applicant board; (2) the written co-applicant agreement and co-applicant board Bylaws must be two separate documents that are presented to HRSA for review and approval; and (3) no employee or immediate family member of an employee of the public agency may serve on the co-applicant board.
  • Incorporation of the existing proscriptions in the affiliation policies regarding the limited involvement of third parties in board composition and decision-making (previously published in PIN #97-27 and PIN #98-24).
  • Incorporation of required Bylaws provisions and board involvement in certain activities, both of which previously were suggestions only.

HRSA indicated that the new PIN was effective upon publication.  Health centers should review their governance structures, Bylaws, and affiliation and co-applicant agreements (as applicable) for compliance with PIN #2014-01 or risk the placement of grant conditions for identified non-compliance with governance requirements consistent with the Progressive Action Process outlined in PAL #2010-01.

 Revised Health Center Program Site Visit Guide

In addition to PIN #2014-01, HRSA issued a revised version of the Health Center Program Site Visit Guide (the Guide), which serves as the main review tool utilized by HRSA consultants when conducting Operational Site Visits (OSVs).  The new Guide applies to both grantees and look-alike organizations.  It reflects key structural changes to the OSV process and incorporates the requirements of the new governance PIN.  As such, it is critically important that all health centers review the revised Guide, in particular those centers for which OSVs will be conducted within the coming months.

In general, the updated Guide clarifies the nineteen Program Requirements that form the framework of compliant health center programs and reflects a shift in the OSV process to focus primarily on compliance with such requirements.  Other than a few revisions under Requirement #17: Board Authority and Requirement #18: Board Composition to reflect the policy clarifications and modifications in PIN #2014-01, the revised Guide does not reflect substantive changes to the program requirements.  Rather, key modifications focus on ensuring greater objectivity among reviewers, include the following:

  • Sections I – IV, which comprise the compliance assessment of the Nineteen Program Requirements, were modified to remove the performance improvement questions specific to each requirement.  Further, the compliance questions were stream-lined and clarified, and each requirement now includes a list of the documents that the consultants will review either on-site during or in advance of the OSV to assess compliance, which is separate from the list of HRSA resources provided as background for each requirement.
  • NEW Section V includes the clinical and financial performance measures that were previously included within the program requirements, and clarifies and stream-lines the instructions for assessing and documenting the health center’s progress.
  • NEW Section VI assesses the health center’s progress in completing activities funded under one-time capital grants awarded under the Affordable Care Act.
  • NEW Section VII documents innovative/best practices conducted by the health center that the reviewers observed during the OSV.

HRSA indicated that the new steam-lined process was established in response to feedback it received from health centers (as well as Primary Care Associations and NACHC) and should result in objective, in-depth assessments of compliance while minimizing subjectivity.

Please let us know if you have any questions about these new documents, or any other issues that might arise.