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Rural Referral Centers

Eligibility

Rural Referral Centers are high-volume acute care rural hospitals that treat a large number of complicated cases.  The Centers for Medicare and Medicaid Services classifies hospitals as Rural Referral Centers.   Rural Referral Centers are defined in Section 1886(d)(5)(C )(i) of the Social Security Act; requirements for Rural Referral Centers can be found at 42 CFR 412.96.  For more information about Rural Referral Centers, see Rural Referral Center Fact Sheet (PDF – 645  KB).

Hospitals classified as Rural Referral Centers may be eligible to participate in the 340B Drug Pricing Program if they 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).

Rural Referral Centers may also register their outpatient clinics.

Registration

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 Rural Referral Center’s registration will be accepted:

• Basic contact information
• Medicare Cost Report Worksheets – from the most recently filed Medicare Cost Report:
  • Worksheet E, Part A
  • Worksheet S, appropriately signed and dated
  • Worksheet S-2
  • Worksheets A and C (if registering any outpatient facilities)
    • Sample Trail Balance Sheet (PDF - 250 KB)
• 340B Program Documents
  • Signed Certification of Contract form if the hospital has a contract with the State or Local Government to provide healthcare services to low income patients.
  • Signed Hospital Certification of Ownership/Operation by a unit of State/Local Government form if the hospital is owned or operated by the State or Local Government.
  • The following information if the hospital is a Public or Private Non-Profit Hospital formally granted Governmental powers. HRSA is aware of the complex nature of this category and reserves the right to request additional information and documents from the hospital to ensure that this eligibility criteria is met.
    1. the identity of the government entity granting the governmental power to the hospital;
    2. a description of the governmental power that has been granted to the hospital and a brief explanation as to why the power is considered to be governmental; and
    3. a copy of an official document issued by the government to the hospital that reflects the formal granting of governmental power.
• Medicaid Billing Information – Know how your entity will bill Medicaid to comply with the duplicate discount prohibition; see Medicaid Exclusion/Duplicate Discount page for more information.  

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.

Registration Resources

Rural Referral Centers: 340B Eligibility, Enrollment and Participation (PDF - 175 KB) reference sheet that includes list of required documentation