Health Center Regulatory Issues

HRSA Issues Two New PALs Impacting Health Center Operations

HRSA Issues Second Program Assistance Letter Explaining the Scope Alignment Validation Process

As noted in the Policy Shop on May 20, 2014, in mid-May HRSA issued a new Program Assistance Letter (PAL) describing updates to the Scope of Project forms for services and sites (Forms 5A and 5B, respectively), which served as the first step in an overall scope alignment process (PAL #2014-06: Documenting Scope of Project in Updated Forms 5A and 5B). At that time, HRSA indicated that it would issue a second PAL explaining the actual Scope Alignment Validation (SAV) process – a one-time only opportunity for health centers to validate the data migrated from the old forms to the new forms and to make certain changes necessary to ensure the accuracy of services and sites listed as “in-scope” without submitting full Change in Scope (CIS) requests.

On June 10, 2014, issued the second PAL, entitled “PAL #2014-07: Scope Alignment Validation in HRSA Electronic Handbooks.” HRSA indicated that it will migrate the data from the current scope forms included in the Electronic Handbook (EHB) into the new forms as of June 27, 2014, after which health centers will have almost a month (between June 30, 2014 – July 23, 2014) to complete the validation process (i.e., make any necessary changes and verify accuracy). Until the SAV process is complete, the current scope forms will remain effective. If a health center does not complete its validation by July 23, 2014, the forms will be updated to reflect the data that was migrated by HRSA (i.e., the data as of June 27) and any changes thereafter will require submission of a formal CIS request(s). As such, it is important that every health center review their new forms after migration and make any necessary changes prior to July 23, 2014 or risk losing this one-time opportunity for easy modification.

In general, each health center is expected to review the data migrated to the new forms, either accept it or make limited changes as necessary to ensure accuracy, and certify that the forms (as updated) are accurate OR identify that additional changes that could not be made during the SAV process are necessary. The types of revisions that can be made during the SAV process are summarized in table 1 on page 3 of the PAL. Of importance, particularly for those centers facing an upcoming Operational Site Visit (OSV), health centers may be able to use the SAV process for some “common clean-up” modifications, including, but not limited to:

  • Breakout of psychiatry from general behavioral health and adding it as a separate Additional/ Specialty Service (rather than submitting a CIS request to “correct” or “fix” Form 5A to reflect current HRSA policy regarding specialty services), provided that psychiatry is currently furnished by the health center and behavioral health is already included in its approved scope of project; and
  • Deletion of “x” under Column III of Required Services or Column III of Additional/Specialty Services for services that are also available directly and/or by contract (Columns I and/or II)
  • Deletion of “x” under Column III of Additional/Specialty Services only for services available solely through referral arrangements.

These last two actions are particularly important for health centers whose forms reflect that they provide certain services through formal referral arrangements (Column III) but that do not have written agreements in place to document the arrangements, consistent with HRSA requirements.

In addition to making changes, health centers also should identify any changes required for accuracy that are not allowed pursuant to the table and/or that cannot be performed under the SAV process. HRSA will follow up with those centers and may require submission of full CIS requests consistent with the current policy.

Health centers should note that the CIS module in the EHB will be suspended during the validation period (i.e., from June 27, 2014 at 5:00 PM eastern to July 24, 2014). Any CIS requests approved by HRSA that are pending health center verification at the time of the shut-down will remain pending until after the SAV process. As such, health centers with approved CIS requests that have not yet been verified should use best efforts to verify implementation prior to that time, or risk waiting another month to do so.

Further, complete submissions submitted prior to 5:00 PM eastern on June 27, 2014 will be reviewed during the suspension. If a CIS request is initiated but not completed prior to that date, HRSA will move it into an inactive status and will require re-submission when the system is back up after completion of the SAV process.

HRSA Issues Program Assistance Letter Revising the Progressive Action Process

On June 11, 2014, HRSA issued Program Assistance Letter (PAL) #2014-08: Health Center Program Requirements Oversight, which updates the current Progressive Action process utilized by HRSA when an instance of a health center grantee’s non-compliance with Program Requirements is identified. The PAL also clarifies the actions HRSA will take when a grantee materially fails to comply with the terms of the Section 330 grant and in particular, the actions it will take when the grantee exhausts the Progressive Action process. The PAL supersedes PAL #2010-01, the current Progressive Action policy.

The general framework for the Progressive Action process remains the same – an instance of non-compliance will result in a grant condition detailing the area of non-compliance and the action that must be taken by the grantee to correct. Thereafter, the grantee will have ninety (90) days to provide documentation of compliance or present an action plan to come into compliance; if the action plan is accepted, an additional 120 days will be afforded for implementation. If the proof of compliance or the plan is not accepted, or if the grantee fails to respond or to implement an accepted plan, the grantee will be afforded sixty (60) days to respond (Phase Two), followed by a “last chance” thirty (30) days (Phase Three).

Conditions in Phase Two or Phase Three will be included in a grantee’s “Health Center Profile” on the BPHC website. Further, grantees that have failed to meet conditions by the end of Phase Three will have materially failed to comply with the terms and conditions of their grant award, resulting in the issuance of a new service area competition to re-compete the grant. Grantees in that position may also face shortened project periods and the withdrawal of support through the cancellation of all or part of the grant award before the current project period expires.

Although conditions typically arise through the Operational Site Visit (OSV) review, HRSA also reserves the right to review compliance through various other means, including, but not limited to, on-site reviews in addition to the OSV and paper reviews. If those assessments determine that the grantee has not complied with the conditions from previous awards or that a condition was lifted based on false information, a special award condition may be imposed. Grantees with special award conditions will be afforded a one-time only opportunity to respond within sixty (60) days to avoid penalties for material failure.

In reiterating and clarifying the existing Progressive Action process, the PAL emphasizes the importance of complying with grant conditions in a timely manner. Given the extent of consequences for failure to do so, including the enforcement actions described above as well as placement of a “high risk” designation and awarding of one-year project periods (which in turn may impact the ability of a grantee to compete for additional funds), it is vitally important that each grantee review the process described in this PAL and use best efforts to comply, as applicable.