Sole Community Hospitals are designated by the Centers for Medicare and Medicaid Services. The defining legislation for Sole Community Hospitals is Section 1886(d)(5)(D )(iii) of the Social Security Act. For more information on Sole Community Hospitals, see Sole Community Hospitals Fact Sheet (PDF - 983 KB).
To be eligible to participate in the 340B Drug Pricing Program, Sole Community Hospitals must also have a disproportionate share adjustment percentage equal to or greater than 8 percent for the most-recently filed Medicare cost report and meet the requirements of 42 USC 256b(a)(4)(L)(i).
Sole Community Hospitals may also register their outpatient clinics.
Know your eligibility. Only nonprofit organizations with specific Federal designations or funding are eligible to participate in the 340B Drug Pricing Program.
Be aware of the latest registration dates and deadlines. The current registration periods are listed on the top right corner of this page, along with a link to the OPA database and registration forms. The registration forms are open only during the registration periods.
Identify your Authorizing Official. This individual must be someone who can legally bind the organization to a contract, such as a CEO, COO, or CFO. This is the only person who may submit the 340B on-line registration. You may designate another employee (not a consultant or contractor) to serve as the primary contact.
Prepare to complete registration in one session. You must complete the on-line registration in one session. Registrations left uncompleted will become inactive and close automatically. If this occurs you will need to start at the beginning of the process.
Collect required information. Have the following information on hand to ensure your Sole Community Hospital’s registration will be accepted:
Submit required documentation the same day you submit your registration. E-mail or fax all documentation to the address/number listed on the registration confirmation screen. Hospitals must submit all necessary documentation at the same time that registrations are completed. If all required documentation is not submitted on the same day as the registration, the registration will be deleted from the Office of Pharmacy Affairs database and you will have to reapply by completing a new registration as soon as you have all the required documentation. You may reapply for the same quarter as long as you are within the allotted registration period.
Once approved, an e-mail confirming successful enrollment in the 340B Program will be sent to the authorizing official designated in the registration. This email will include the date on which you may begin purchasing 340B discounted drugs and your entity’s 340B identification number. The 340B identification number is your entity’s unique number that manufacturers, wholesalers, and others will use to verify your participation in the 340B Program. You should also use this number to regularly verify that your entity’s information is up-to-date in the 340B Program database. It is the covered entity’s responsibility to ensure that covered entity database information is current at all times.
Sole Community Hospitals: 340B Eligibility, Enrollment and Participation (PDF - 127 KB) reference sheet that includes list of required documentation.
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Hospitals that are eligible to participate in the 340B Drug Pricing Program in more than one category may select one. For example, a hospital that is both as a Disproportionate Share Hospital and a Sole Community Hospital may choose either type of eligibility and must abide by requirements and guidelines for that type of eligible organization/covered entity once enrolled.