screenshot of HRSA Office of Pharmacy Affairs 340B welcome page
HRSA is seeking comment on plans to revise online forms covered entities must fill when they enroll in the 340B program, recertify their eligibility annually, or update information in 340B OPAIS, the federal 340B program database.

HRSA Seeks Comments on Proposed Changes to 340B Program Forms

The U.S. Health Resources and Services Administration (HRSA) is seeking comment on plans to revise online forms covered entities must fill out when they enroll in the 340B program, recertify their eligibility annually, or update information in 340B OPAIS, the federal 340B program database.

HRSA posted a Federal Register notice this morning about the proposed revisions. It updated the forms last in 2019. A 1980 federal law to cut government red tape puts an expiration data on all such forms. The ones HRSA wants to revise expire on Nov. 30.

There will be two public comment periods on HRSA’s proposed revisions—this one (for 60 days) and a second one (for 30 days) after the White House Office of Management and Budget signs off on HRSA’s proposed changes. The first comment period ends on Aug. 15. The second probably will be announced late this summer. 

HRSA wants to make changes to these forms:

  • 340B Program Registrations & Recertifications for Hospitals (applies to all hospital types). Hospitals would no longer have to supply contact information for a government official who attests to the hospital’s 340B classification type. 
  • 340B Registrations & Recertifications for Ryan White Entities. Ryan White clinics would no longer have to supply their Notice of Funding Opportunity number when they register in 340B or recertify their eligibility.
  • 340B Registration, Recertification & Change Requests for Shipping Address. HRSA said it wants to provide “additional clarification for covered entities to complete the shipping address section in 340B OPAIS to assist in determining the exact shipping address location and relationship to the covered entity.”
  • 340B Program Registrations, Recertifications & Change Requests for Hospitals (applies to rural referral centers and sole community hospital entity types). HRSA said 340B OPAIS “if applicable” would prompt RRCs and SCHs to supply documentation supporting their eligibility sooner during the registration, recertification, or change request submission process.
  • 340B Program Change Requests for Hospitals. HRSA would start letting hospitals revise “hospital qualification information such as, the Disproportionate Share Adjustment Percentage, control type, hospital classification, and contract start date” under a change request submission as well as during recertification.
  • 340B Primary Contact and Authorizing Official Information: HRSA wants to remove the fax telephone number field.
  • 340B Program Recertifications & Change Requests for Hospitals. HRSA said it wants to clarify when a covered entity would initiate a name change in 340B OPAIS. “If applicable, 340B OPAIS will prompt the covered entity for documentation that supports the name change, which will be attached as part of its recertification or change request submission. Currently, the request for the supporting name change documentation is obtained during the submission review process.”
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