![]() UPDATE: Earlier this year, we revised the hospital registration instructions to more clearly describe the documentation required to show program eligibility as well as the process of submitting that documentation for review by OPA. We are now pleased to announce a new collaboration with the Centers for Medicare and Medicaid Services (CMS) that will allow us to verify most hospital cost report and provider enrollment data electronically. OverviewEffective with the next registration period (July 1-15, 2014), most registrants will no longer be required to submit Medicare cost report worksheets and trial balances to OPA by e-mail or fax for review. During registration, the 340B database will use the most recent data available from CMS data sources. The database will display to the user the hospital’s cost reporting period that provided this data. (Government ownership/operation or contractual arrangements will be verified electronically as well; paper certifications with actual ink signatures are no longer required.) We have additional resources on this change here: Hospital Registration Instructions Hospitals are still 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 latest filed cost report:
ProcessOPA 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 that are entered by the hospital must be verifiable by supporting documentation. This documentation is only necessary to provide if requested. 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:
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). Update: Registrants must provide the name, title, organization and contact information 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 within the next five calendar days. If the government official fails to respond to the e-mail within 5 days of the submission or the end of the registration period, whichever comes first, the hospital’s registration will be deleted without further review.
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. TO AVOID DELAYS IN YOUR REGISTRATIONIf the information received from CMS is current and correct, submission of worksheets and trial balances by e-mail or fax is not required. If a more recently filed cost report is available, or the hospital otherwise submits corrections to the pre-identified information, the appropriate documents must be submitted on the same day as the underlying registration. OPA has established specific e-mail addresses and fax numbers for each registration type; please e-mail or fax materials to the appropriate address or number for your hospital type. Hospitals MUST include their Medicare provider number in the subject of their e-mail or include it prominently on their fax cover sheet.
Health Resources and Services Administration We hope this information is useful and welcome feedback at any time to continue to improve transparency as we strengthen our program integrity efforts. A summary of this information, along with sample cost report worksheets and a sample trial balance is available at Hospital Registration Instructions (PDF - 71 KB). 04/08/2014 |
- Grants
- Loans & Scholarships
- Data Warehouse
- Training & TA Hub
- Behavioral Health
- Care Teams
- Child and Adolescent Health
- Chronic and Infectious Diseases
- Financing
- Health Information Technology
- HIV/AIDS
- Maternal Health
- Older Adult Health
- Oral Health
- Performance Measurement & Quality Improvement
- Research
- Rural Health
- Social Determinants of Health
- Telehealth
- Training Centers
- Workforce
- About HRSA