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H H S Department of Health and Human Services
Health Resources and Services Administration
Health Resources and Services Administration

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Freestanding Cancer Hospitals

Eligibility

Freestanding Cancer Hospitals are independent, non-profit hospitals that treat patients with cancer. For-profit hospitals are not eligible to participate in the 340B program.

To be eligible to participate in the 340B Drug Pricing Program, Freestanding Cancer Hospitals must either

  • Have a disproportionate share adjustment percentage greater than 11.75 percent for the most-recently filed cost report; or
  • Be eligible under a separate indigent care calculation that meets specific criteria including location in an urban area, 100 or more beds and net inpatient care revenues (excluding Medicare) for indigent care of more than 30 percent of net during the cost reporting period in which the discharges occur. This indigent care revenue must come from State and local government sources and Medicaid.

The defining legislation for Freestanding Cancer Hospitals is Section 1886(d)(1)(B)(v) of the Social Security Act.

Freestanding Cancer Hospitals may also register their outpatient clinics.

Registration

Registration Tips Step 1.Know your eligibility. Only nonprofit organizations with specific Federal designations or funding are eligible to participate in the 340B Drug Pricing Program.

Registration Tips Step 2. 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.

Registration Tips Step 3.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.

Registration Tips Step 4.Prepare to complete 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.

Registration Tips Step 5.Collect needed information. Have the following information on hand to ensure your Freestanding Cancer Hospital’s registration will be accepted:

  • Basic contact information
  • Medicare Cost Report Worksheets:  

    • Worksheet E, Part A
    • Worksheet S, appropriately signed and dated
    • Worksheet S-2
    • Worksheets A and C – Required if hospital is registering outpatient facilities.
  • 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.

Registration Tips Step 6 Submit required documentation immediately by e-mail or fax 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

Freestanding Cancer Hospitals: 340B Eligibility, Enrollment and Participation (PDF – 171 KB) reference sheet that includes list of required documentation

Registration Now

RegisterStart Date
January 1-15April 1
April 1-15July 1
July 1-15October 1
October 1-15January 1
Eligible in Multiple Categories

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.

Questions, contact ApexusAnswers@340BPVP.com or call 1-888-340-2787 Monday through Friday 8:30am to 6:30pm