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Children's Hospitals

Eligibility

Children's Hospitals are hospitals with inpatients predominantly age 18 or younger. Their Medicare Provider Numbers begin with 3300.

To be eligible to participate in the 340B Program and purchase outpatient drugs at significantly discounted prices, children’s hospitals must be

  • A private nonprofit hospital under contract with State or local government to provide health care services to low income individuals who are not eligible for Medicare or Medicaid; or
  • Owned or operated by a unit of State or local government; or
  • A public or private nonprofit corporation that is formally granted governmental powers by a unit of State or local government.

For-profit hospitals are not eligible to participate in the 340B program.

To be eligible to participate in the 340B Drug Pricing Program, Children’s 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 Children’s Hospitals is Section 1886(d)(1)(B)(iii) of the Social Security Act.

Children’s Hospitals may also register their outpatient clinics.

Registration

Before Beginning Your Registration

  1. Know your eligibility. Only nonprofit organizations with specific Federal designations and/or funding are eligible to register with and be approved to purchase discounted drugs through the 340B Drug Pricing Program. 
  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. 
  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. 
  4. 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. 
  5. Collect required information. Have all the necessary information on hand to ensure your Hospital registration will be accepted.
  6. Submit required documentation immediately upon completion of your registration.

If the information received from CMS is current and correct, submission of worksheets and trial balances is not required. If a more recently filed cost report is available, or the hospital otherwise submits changes to the pre-identified information, the required documents must be submitted on the same day the registration is submitted. For details, please refer to the Hospital Registration Instructions.

Overview

As of July 2014, most registrants will no longer be required to submit Medicare cost report worksheets and trial balances to OPA for review. The 340B database will use the most recent data available from CMS data sources. The database will display the hospital’s cost reporting period from which this data came. 

Government ownership/operation or contractual arrangements are verified electronically as well; paper certifications with actual ink signatures are no longer accepted. This is a time-sensitive process, so review the instructions below carefully. 

Hospitals are encouraged to have the relevant documents available when registering to confirm that the data received from CMS is current and complete; hospitals registering additional outpatient sites will also be asked to enter several figures from Worksheet A, Worksheet C and the associated working trial balance from the hospital’s latest filed cost report:

  • Total expenses for the cost center/line associated with the site being registered (Worksheet A, Column 7) 
  • Outpatient charges associated with the cost center/line being registered (Worksheet C, Column 7) 
  • Expenses associated with the specific clinic, service or facility being registered. If more than one clinic, service or facility is rolled up to a single cost center, these figures will come from the working trial balance. For cost centers/lines that reflect only a single outpatient clinic, service or facility, these figures will come directly from Worksheet A, Column 7 and will be the same as those provided above under the first bullet.
  • Outpatient revenue associated with the specific clinic, service or facility being registered; these figures will come from the working trial balance as well. 

Additional resources for hospital registrations are available here: 

Hospital Registration Webinar 

Hospital Registration Instructions

Sample Working Trial Balance

Hospital Registration Review Process

OPA and CMS are working closely to ensure that the most recent cost report and provider enrollment data are available to facilitate 340B registration. OPA verifies information on net expenses and outpatient charges with CMS data. Information on service/clinic cost and revenue entered by the hospital must be verifiable by supporting documentation. This documentation should be submitted only if requested. 

When to submit supporting documents: If the data entered by the hospital regarding qualification information, net expenses, and/or outpatient charges, differs from what CMS provided to OPA, an alert will appear. In these cases, the hospital must submit supporting documents as described in the Hospital Registration Instructions. The hospital must submit the required documents by e-mail or fax on the same day as the registration. When submitting documents via e-mail, hospitals MUST include their Medicare provider number in the subject line of all communication with OPA. Affected registrations submitted without these documents will be deleted without being reviewed.

Whether the requested data is received from CMS or by e-mail/fax directly from the hospital, the review steps are the same. OPA staff will ensure that the hospital meets the eligibility criteria established in the 340B statute and will reach out to the authorizing official listed on the registration for any necessary clarifications. Specific considerations include but are not limited to: 

1. Ownership classification – To qualify for the 340B program, registrants must be: 

    1. Owned or operated by a State or Local government 
    2. A private, non-profit hospital with a valid contract with a State or Local government to provide health care services to low-income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid 
    3. A public or private non-profit hospital that has been formally granted governmental powers. This category of hospitals must provide the following: 
      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. 

If non-profit status for hospitals reporting eligibility via a government contract or grant of governmental powers cannot be verified by the information received from CMS, the registrant must also provide independent verification (e.g., articles of incorporation or IRS exemption determination/affirmation letter). 

Important: New/parent hospital registrants must provide the name, title, organization and contact information, including a valid email address, for a government official that can certify the public ownership/operation and/or an appropriate contractual relationship; that individual will be contacted by e-mail and requested to verify the registrant’s status by following the link provided in the email within the next five calendar days, or by the end of the registration period, whichever comes first. If the government official fails to respond to the e-mail within this time frame, the hospital’s registration will be deleted without further review

2. Hospitals - For all hospital registrations, OPA reviews information from the following Medicare cost report worksheets (or their electronic equivalents) to ensure that the hospital meets 340B program eligibility requirements. 

    1. Worksheet S – OPA reviews the cost reporting period dates, the filed date and the Officer or Administrator of Provider’s signature. 
    2. Worksheet S-2 – OPA reviews the cost reporting period dates, the filed date, and the hospital’s provider number, verifying that it matches Worksheet S. OPA then reviews the address of the main hospital, outpatient provider numbers if applicable (typically found on Lines 15-18), as well as the hospital type of control (Line 21). 
    3. Worksheet E, Part A, for DSH, RRC, SCH, and CAN hospitals – OPA reviews the cost reporting period dates, the filed date, and the hospital’s provider number, verifying that it matches Worksheet S. OPA then reviews Line 33 to confirm the disproportionate share adjustment percentage. This worksheet is not reviewed for CAH or PED hospitals. 
    4. Worksheet S-3, for PED hospitals only – OPA reviews the cost reporting period dates, the filed date, and the hospital’s provider number, verifying that it matches Worksheet S. OPA uses the data from this worksheet to calculate the Disproportionate Patient Percentage (DPP), which is then applied to CMS’s DSH adjustment percentage formula to determine the hospital’s allowable disproportionate share adjustment percentage. If the cost report does not have sufficient information to calculate the DSH adjustment percentage, see Section D (Process for Admission of Children’s Hospitals to the340B Program) of the 340B program guidance at http://edocket.access.gpo.gov/2009/pdf/E9-21109.pdf

3. Outpatient Facilities - For outpatient facility registrations, OPA reviews information from the Medicare cost report worksheets as described under section 2 above. OPA also reviews Worksheets A & C, and a working trial balance or similar budget document. 

    1. Worksheet A – OPA reviews the cost reporting period dates, the filed date, and the hospital’s provider number, verifying that it matches the other worksheets. OPA then reviews the worksheet to ensure that the clinics being registered are located under eligible cost center categories. 
    2. Worksheet C – OPA reviews the cost reporting period dates, the filed date, and the hospital’s provider number, verifying that it matches the other worksheets. OPA then reviews the worksheet to ensure that the clinics being registered are located under eligible cost center categories and have associated outpatient activity. 
    3. Working Trial Balance – OPA requests a working trial balance or a similar budget document if costs from the site being registered are distributed across multiple cost centers, or if the site is rolled up with other clinics into a single cost center. OPA reviews this to see how the site being registered correlates to the associated cost center from Worksheet A and Worksheet C. 

Important note: All outpatient clinics and services that are located outside of the four walls of the hospital and that intend to use or purchase 340B drugs for its patients must register with the 340B program. They must appear on the hospital’s most recently filed cost report in order to register. 

If an off-site location is actually a separate hospital or medical center, or even a small office with several services being provided, each clinic/department/service must be registered separately in the 340B program database. For example, if there is a single off-site location that provides radiology services, physical therapy services, and pediatric services, the covered entity should register each service individually to establish its eligibility for 340B drugs.

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 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