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.
Effective 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 Webinar
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:
- 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.
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 that are entered by the hospital must be verifiable by supporting documentation. This documentation is only necessary to provide if requested.
If the data entered by the hospital on net expenses and outpatient charges differs from what CMS provided to OPA, a blue box will appear with an alert. In this case the hospital must submit worksheets A and C from the latest filed cost report, and the associated working trial balance. The hospital must submit this documentation 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 their initial message and any subsequent 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:
- Ownership classification – To qualify for the 340B program, registrants must be:
- Owned or operated by a State or Local government
- 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
- A public or private non-profit hospital that has been formally granted governmental powers. This category of hospitals must provide the following:
- The identity of the government entity granting the governmental power to the hospital;
- 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
- 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).
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.
- Hospitals - For all new 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.
- Worksheet S – OPA reviews the cost reporting period dates, the filed date and the Officer or Administrator of Provider’s signature.
- 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).
- 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.
- 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.
- Outpatient Facilities - For outpatient facility registrations, OPA again reviews information from the Medicare cost report worksheets as described above. OPA also reviews Worksheets A & C, and a trial balance or similar budget document. 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.
- 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.
- 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.
TO AVOID DELAYS IN YOUR REGISTRATION
If 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.
|Registration Type|| E-mail address|| Fax|
|Disproportionate Share Hospitals||340BRegistrationDSH@hrsa.gov||301-443-6571|
|Critical Access Hospitals||340BRegistrationCAH@hrsa.gov||301-443-6572|
|Sole Community Hospitals||340BRegistrationSCH@hrsa.gov||301-443-6573|
|Rural Referral Centers||340BRegistrationRRC@hrsa.gov||301-443-6574|
|Freestanding Cancer Hospitals||340BRegistrationCAN@hrsa.gov||301-443-6575|
OPA does not require original signed documents, but registrants may utilize courier services in lieu of e-mail or fax:
Health Resources and Services Administration
Attn: Office of Pharmacy Affairs
5600 Fishers Lane, 8W03A
Rockville, MD 20857
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).