Program Integrity: Best Practices for Hospital Registrations

March 2015

HRSA’s efforts to improve 340B program integrity are not limited to audits; ensuring the accuracy of initial registrations is a critical priority as well. HRSA has been working to integrate authoritative external data sources with the registration process for the last several years, beginning with the validation of contract pharmacy information via Drug Enforcement Agency databases in March 2013 as well as the simultaneous automatic verification of Consolidated Health Center Program (Section 330) grantees and Federally Qualified Health Center Look-Alike (FQHCLA) organizations using HRSA’s Electronic Handbooks system. These enhancements have yielded improved data quality as well as efficiencies for both registrants and HRSA staff.

In July 2014, HRSA began a new process whereby cost report and provider registration data from the Centers for Medicare & Medicaid Services (CMS) are used to improve the efficiency and integrity of the 340B hospital registration process. Upon registration, the dates of the cost reporting period from the most recently filed report available from CMS are displayed to the hospital, as well as the associated control type (ownership status) and Disproportionate Share adjustment percentage as applicable.  Hospitals registering additional off-site outpatient facilities are prompted to select from a list of practice locations registered with CMS via the CMS-855A/B forms or the Provider Enrollment, Chain and Ownership System (PECOS).

HRSA would like to encourage the following best practices based upon lessons learned during the new hospital registration process:

  • Verify Correct Email of Government Official and Register Early:  Hospital organizations that are entering or re-entering the 340B Program and qualifying on the basis of government ownership/operation or an appropriate contract with a state/local government (see the 340B Eligibility & Registration section of HRSA’s web site) must identify a government official that is able to certify the governmental relationship. The specified government official will receive an e-mail with a link to complete the online certification process and must do so within five calendar days of registration submission.  HRSA strongly encourages verifying that the email address is entered correctly and that the identified government official is expecting the e-mail and is available to complete the online certification within the required five calendar days. HRSA strongly encourages hospitals to register early in the quarter. Hospitals that wait until the end of the registration period and do not obtain the required certification will be unable to re-register until the following quarter.
  • Ensure Appropriate Authorizing Official (AO) Listing:  HRSA has seen a number of cases where a hospital registers as owned/operated by a government body and the same individual is listed as both the hospital’s AO and the certifying government official.  The same individual should not be listed as both the hospital’s AO and the certifying government official.  If this is the case for your particular entity, HRSA encourages you to contact ApexusAnswers prior to registering to discuss the particular situation as well as any supplemental documentation that will be necessary to determine eligibility.
  • Have Your Cost Report Available:  Most hospitals no longer need to routinely submit cost report worksheets and associated trial balances, but HRSA strongly recommends having the entire report available at the time of registration. Information from the worksheets (and associated trial balance, for outpatient registrations) will need to be entered during the registration process.  In addition, HRSA may not always have access to a hospital’s most recently filed report due to the timelines involved in CMS’s receiving, validating and making the information available to its external partners. The 340B database will prompt affected registrants to update their cost report information if the cost report dates available to HRSA are more than 18 months old and the hospitals would have filed a more recent cost report. Affected hospitals are required to submit their most recently filed cost report and supporting documents on the same day as the affected registrations.  HRSA reserves the right to request additional documentation at any time to support its review of the registration.  Hospitals must include their provider number in the subject line of their email when submitting the required supporting documentation.
  • Submit a Separate Registration for Each Service Off-Site the Parent:  Hospitals registering off-site outpatient facilities are asked to select from the practice locations previously identified to CMS; please note that the 340B database will allow users to enter locations that are not listed.  In doing this, the hospital must submit their most recently filed cost report worksheets and associated trial balance to the appropriate email address.  HRSA requires individual registrations of each service within participating off-site outpatient facilities.  In the event that each location contains multiple services, the entity must submit a separate registration for each service.
  • Identify the Worksheet A/C Cost Center Line(s) Associated With Each Off-Site Outpatient Site/Service registration:  The 340B database supplies a list of lines from the organization’s most recently filed report and accessible by CMS but registrants may also enter their own line/subscript information in case the available report is from a prior year and the site/service is reported on a line not in use at the time. Please note that the registration form requires the figures from Column 7 for each Worksheet A and C which show outpatient charges. 
  • Changes in Hospital Type Should Be Treated as a New Registration:  Hospitals changing their registration type (for example, changing from a disproportionate share hospital to a sole community hospital) must follow all registration requirements and instructions as if they are a new hospital registration.  Additional documents may be requested from HRSA to verify the change in hospital type and to ensure all eligibility requirements are met.  These hospitals will also have to resubmit any contract pharmacy registrations associated with their hospital once their new 340B IDs have been assigned.

HRSA appreciates the cooperation of the 340B community as we continue to refine the hospital and non-hospital registration processes in support of an effective, efficient and transparent program. We anticipate the integration of additional external grantee data sources in late 2015 or early 2016.

As always, the team at ApexusAnswers – a service of the 340B contracted Prime Vendor Program – stands ready to assist with any questions or concerns by e-mail (ApexusAnswers@340bpvp.com), phone (888-340-2787) or online chat.

Date Last Reviewed:  April 2017